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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Eye
510(k) Number K861456
Device Name SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR
Applicant
Pantheon Products, Inc.
Rte. 1
Box 209w
Odessa,  TX  79766
Applicant Contact RAQUEL SHEETS
Correspondent
Pantheon Products, Inc.
Rte. 1
Box 209w
Odessa,  TX  79766
Correspondent Contact RAQUEL SHEETS
Regulation Number878.4440
Classification Product Code
HMP  
Date Received04/18/1986
Decision Date 07/25/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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