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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bag, reservoir
510(k) Number K940220
Device Name REBREATHER BAGS
Applicant
ZEFON MEDICAL PRODUCTS
5350 SOUTHWEST FIRST LN.
OCALA,  FL  34474
Applicant Contact ROBERT L STONE,JR
Correspondent
ZEFON MEDICAL PRODUCTS
5350 SOUTHWEST FIRST LN.
OCALA,  FL  34474
Correspondent Contact ROBERT L STONE,JR
Regulation Number868.5320
Classification Product Code
BTC  
Date Received01/21/1994
Decision Date 05/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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