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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K830737
Device Name JERMYN OCCLUDERS KIT
Applicant
Jermyn Specialties of California
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Jermyn Specialties of California
4221 Richmond Rd., NW
Walker,  MI  49534
Date Received03/08/1983
Decision Date 06/02/1983
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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