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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 K810152
Device Name X-VEE
Applicant
TEMPORATY SURGICAL SYSTEMS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
TEMPORATY SURGICAL SYSTEMS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number886.4150
Classification Product Code
HKP  
Date Received01/21/1981
Decision Date 03/17/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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