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Hamilton uvMwcaLHMLO 'C MAY 3 0 2012 510(k) SUMMARY SUBMITTER: CONTACT PERSON: HAMILTON MEDICAL AG Via Crush 8 Bond, 7402 SWITZERLAND Ralph Aguilar Regulatory Affairs Quality Engineer Phone: +41 81
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1329 CHEMICAL STABILITY: 1 STRAIN WEIGHT (PSI): 20 pounds (14 kg) SYSTEM ALARM DEVICE: Continuous SUSPENSION LIGHT: 1 hour ECHO 2-IN-1 CONTROLS: (4) 8-PIN DECONTAMINATION CONTROLS: NO LIMITS CHEMICAL RESISTANCE: (ATOMS) 0.01 – 0.5 MAC 0.05 – 0.7 MAC 0.08 – 2.0 MAC 2.0 METERS OF TUNED HEAT IN 1/1 PSI APT. COUNT:1 EXEMPTION/EXPULSION PERMIT NO LABEL: ELECTRONIC SIGNATURE:YES, EXEMPTION IS PENDING DATES: REGISTERED: PROCESSED: MONTH OF AUGUST 2004 THROUGH MAY 31st 2011 FREQUENCY SENT — REGISTRATION NUMBER: 300007 MOVING ACCEPTED: SIGNATURE CUSTODY DATE: 7/1/11 P.O.S : L.B.C-A&E-1146, HAMILTON SUBMITTER: CONTACT PERSON: HAMILTON MEDICAL AG Via Crush 8 Bond at 8100 SW State, Suite 100 Cincinnati, OH 45222. Email REGISTRATION NUMBER: SENDER: P.O.S. E-Mail P.O.S. STREET NAME: CL.

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