FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

REFLEX(TM) CA-T CLIP APPLIER

K Number: K873309 · Decision Nov 27, 1987
Classifications
1
FEI Numbers
112
Registration Numbers
112
Same Product Code
175
Applicant Total
33
Review Days
101

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Basic Information

Device Name
REFLEX(TM) CA-T CLIP APPLIER
K Number
K873309
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4300
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Richard-Allan Medical Ind., Inc.
Date Received
August 18, 1987
Decision Date
November 27, 1987
Product Code
FZP
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
FZP Clip, Implantable

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Other Clearances by Richard-Allan Medical Ind., Inc.

K Number Device Name
K931879 REFLEX HTR
K924200 REFLEX(R) ESC
K926297 REFLEX ESI
K924761 STERILE ENDOSCOPIC DISPOS TROCARS W/SAFE SHIELD
K900566 RICHARD-ALLAN VESSEL LOOPS
K896262 TITANIUM LIGATING CLIPS
K890314 PROTECTOR (SURGICAL INSTRUMENT)
K862404 REFLEX(TM) CLIP APPLIER
K862223 MICRO THIN* PARAFFIN
K861890 100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2
Search all 33 clearances from Richard-Allan Medical Ind., Inc. →