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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape, Measuring, Rulers And Calipers
510(k) Number K863409
Device Name KUNDIN WOUND GAUGE
Applicant
Jane I. Kundin
1288 Laurel Hill Dr.
San Mateo,  CA  94402
Correspondent
Jane I. Kundin
1288 Laurel Hill Dr.
San Mateo,  CA  94402
Regulation Number878.4800
Classification Product Code
FTY  
Date Received09/03/1986
Decision Date 09/29/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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