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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Vitreous Aspiration And Cutting, Battery-Powered
510(k) Number K822599
Device Name KEATES I/A SYSTEM FRIGITRONICS 4000
Applicant
Frigitronics of Connecticut, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Frigitronics of Connecticut, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number886.4150
Classification Product Code
HKP  
Date Received08/27/1982
Decision Date 10/06/1982
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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