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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Frozen Donor Tissue Storage
510(k) Number K860511
Device Name AMPU-PAK
Applicant
Ammerman Medical Enterprises, Inc.
1180 Oleander Dr.
Naples,  FL  33940
Applicant Contact ANDERSON M.D.
Correspondent
Ammerman Medical Enterprises, Inc.
1180 Oleander Dr.
Naples,  FL  33940
Correspondent Contact ANDERSON M.D.
Classification Product Code
LPZ  
Date Received02/11/1986
Decision Date 08/04/1986
Decision Substantially Equivalent (SESE)
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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