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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spatula, Ophthalmic
510(k) Number K801608
Device Name MCCULLEY CONTINUOUS SUTURE TIGHTNER
Applicant
Edward Weck, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Edward Weck, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number886.4350
Classification Product Code
HND  
Date Received07/15/1980
Decision Date 08/12/1980
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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