FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

DDV LIGATOR

K Number: K921304 · Decision Oct 5, 1992
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
43
Applicant Total
1
Review Days
208

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Basic Information

Device Name
DDV LIGATOR
K Number
K921304
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
876.4730
Medical Specialty
Gastroenterology, Urology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
North American Medical, Inc.
Date Received
March 11, 1992
Decision Date
October 5, 1992
Product Code
KOA
Advisory Committee
Gastroenterology, Urology
Review Advisory Committee
GU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
KOA Surgical Instruments, G-U, Manual (And Accessories)

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