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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bougie, Urological
510(k) Number K822711
Device Name ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL
Applicant
Parker Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Parker Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5520
Classification Product Code
FAX  
Date Received09/07/1982
Decision Date 11/03/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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