FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

CASF STERILIZATION TRAY

K Number: K883193 · Decision Aug 10, 1988
Classifications
1
FEI Numbers
875
Registration Numbers
875
Same Product Code
75
Applicant Total
9
Review Days
13

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Basic Information

Device Name
CASF STERILIZATION TRAY
K Number
K883193
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4800
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Terray Manufacturing, Inc.
Date Received
July 28, 1988
Decision Date
August 10, 1988
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 Terray Manufacturing, Inc.

K Number Device Name
K910874 THORACIC ANTERIOR SPINAL FIXATION PLATE
K882934 CASF CANCELLOUS BONE SCREW, BT650
K882871 CASF DRILL GUIDE DG 170
K883125 CASF STERILIZATION TRAY
K870085 ANTERIOR SPINAL FIXATION PLATE
K870082 BONE PLATE
K870083 FERRAY EXTRACTOR
K870084 RD 140 SURGICAL BENDER