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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name conserver, oxygen
510(k) Number K001412
Device Name PM 1800 CONSERVING DEVICE
Applicant
PRECISION MEDICAL, INC.
300 HELD DR.
NORTHAMPTON,  PA  18067
Applicant Contact CONLEY WALLACE
Correspondent
PRECISION MEDICAL, INC.
300 HELD DR.
NORTHAMPTON,  PA  18067
Correspondent Contact CONLEY WALLACE
Regulation Number868.5905
Classification Product Code
NFB  
Date Received05/04/2000
Decision Date 03/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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