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

RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY

K Number: K870417 · Decision Mar 5, 1987
Classifications
1
FEI Numbers
875
Registration Numbers
875
Same Product Code
75
Applicant Total
6
Review Days
30

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Basic Information

Device Name
RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY
K Number
K870417
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4800
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
North Coast Medi-Tek
Date Received
February 3, 1987
Decision Date
March 5, 1987
Product Code
FSM
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
N

Classifications

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

Product Code Device Name
FSM Tray, Surgical, Instrument

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Other Clearances by North Coast Medi-Tek

K Number Device Name
K870419 IVR-SP CUSTOM ANGIOGRAPHY TRAY
K870420 PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY
K870416 LP EXTENSION SETS
K870418 MYA-1 AND MYT-1 MYELOGRAM TRAY
K854095 BIOPSY TRAY I & II