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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Circuit, Breathing (W Connector, Adaptor, Y Piece)
510(k) Number K852405
Device Name LASERSAFE PERSONNEL AND PATIENT SHIELDS
Applicant
Lasersafe, Inc.
641 Ridgefield Ave.
Pittsburgh,  PA  15216
Applicant Contact TEEPLE, M.D.
Correspondent
Lasersafe, Inc.
641 Ridgefield Ave.
Pittsburgh,  PA  15216
Correspondent Contact TEEPLE, M.D.
Regulation Number868.5240
Classification Product Code
CAI  
Date Received06/06/1985
Decision Date 10/01/1985
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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