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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Restraint, Protective
510(k) Number K801272
Device Name TECNOL QUICK RELEASE LIMB HOLDER
Applicant
TECNOL NEW JERSEY WOUND CARE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
TECNOL NEW JERSEY WOUND CARE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received05/28/1980
Decision Date 06/17/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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