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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressings Containing Topical Analgesics
510(k) Number K922636
Device Name HEMO-STAT
Applicant
Mckinley-Ross Laboratories, Inc.
127 Tomahawk Industrial Park
Lynchburg,  VA  24502
Applicant Contact MILLARD MINTON
Correspondent
Mckinley-Ross Laboratories, Inc.
127 Tomahawk Industrial Park
Lynchburg,  VA  24502
Correspondent Contact MILLARD MINTON
Classification Product Code
SEJ  
Date Received05/29/1992
Decision Date 11/09/1992
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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