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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Trephine, Manual, Ophthalmic
510(k) Number K873918
Device Name HEAD & CHIN RESTS
Applicant
Richmond Products, Inc.
1021 So Rogers Cir.
Boca Raton,  FL  33487
Applicant Contact LLOYD POWELL
Correspondent
Richmond Products, Inc.
1021 So Rogers Cir.
Boca Raton,  FL  33487
Correspondent Contact LLOYD POWELL
Regulation Number886.4350
Classification Product Code
HRH  
Date Received09/24/1987
Decision Date 10/28/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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