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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lens, contact (other material) - daily
510(k) Number K954124
Device Name O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS
Applicant
OPTICAL POLYMER RESEARCH, INC.
235 NORTH TALBOT CT.
ROSWELL,  GA  30076 -2480
Applicant Contact WALLY STIRLING
Correspondent
OPTICAL POLYMER RESEARCH, INC.
235 NORTH TALBOT CT.
ROSWELL,  GA  30076 -2480
Correspondent Contact WALLY STIRLING
Regulation Number886.5916
Classification Product Code
HQD  
Date Received09/01/1995
Decision Date 03/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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