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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 K864810
Device Name LIDSPLINT
Applicant
Precision Therapeutics, Inc.
2320 Plz. Del Grande
Las Vegas,  NV  89102
Applicant Contact LEONARDI, M.D.
Correspondent
Precision Therapeutics, Inc.
2320 Plz. Del Grande
Las Vegas,  NV  89102
Correspondent Contact LEONARDI, M.D.
Regulation Number878.4440
Classification Product Code
HMP  
Date Received12/09/1986
Decision Date 01/20/1987
Decision Substantially Equivalent (SESE)
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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