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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., NW
Walker,  MI  49534
Correspondent
United States Surgical, A Division of Tyco Healthc
4221 Richmond Rd., NW
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
Predetermined Change
Control Plan Authorized		 No
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