FDA 510(k) FDA class 2 Substantially Equivalent 🇪🇸 Spain

CONTORNO (TM)

K Number: K902642 · Decision Aug 7, 1990
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
5
Review Days
54

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Basic Information

Device Name
CONTORNO (TM)
K Number
K902642
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4400
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Palex Intl. SA
Date Received
June 14, 1990
Decision Date
August 7, 1990
Product Code
GEI
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
GEI Electrosurgical, Cutting & Coagulation & Accessories

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (GEI), ordered by most recent decision date.

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Other Clearances by Palex Intl. SA

K Number Device Name
K905108 CONTORNO(R), MODELS E AND ST
K904586 PALEX IRRIGATION SET
K903224 EPISENSOR
K901680 BAUMAN RIGID LARYNGOSCOPE