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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Absorbable, (Scleral Buckling Methods)
510(k) Number K831773
Device Name MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK
Applicant
Bcd Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Bcd Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number886.3300
Classification Product Code
HQJ  
Date Received06/02/1983
Decision Date 08/16/1983
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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