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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K854266
Device Name STERILE LASER RESISTANT SURGICAL FIELD DRAPE
Applicant
Lasersafe, Inc.
641 Ridgefield Ave.
Pittsburgh,  PA  15216
Applicant Contact EDWARD TEEPLE
Correspondent
Lasersafe, Inc.
641 Ridgefield Ave.
Pittsburgh,  PA  15216
Correspondent Contact EDWARD TEEPLE
Date Received10/23/1985
Decision Date 03/27/1986
Decision Substantially Equivalent (SESE)
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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