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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drain, Tee (Water Trap)
510(k) Number K790929
Device Name DRAINAGE BAG
Applicant
Mem Medical, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Mem Medical, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5995
Classification Product Code
BYH  
Date Received05/15/1979
Decision Date 05/21/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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