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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name saw, nasal
510(k) Number K810188
Device Name AUTO SUTURE GAS POWERED DISP. LDS STAPL
Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number874.4420
Classification Product Code
KBC  
Date Received01/22/1981
Decision Date 03/20/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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