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

APPARATUS, SUCTION, WARD USE, PORTAB-

K Number: K843750 · Decision Oct 11, 1984
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
151
Applicant Total
2
Review Days
16

Basic Information

Device Name
APPARATUS, SUCTION, WARD USE, PORTAB-
K Number
K843750
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4780
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
H.C.H. PRODUCTS, INC.
Date Received
September 25, 1984
Decision Date
October 11, 1984
Product Code
BTA
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
BTA Pump, Portable, Aspiration (Manual Or Powered)

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K Number Device Name
K852646 THERMATIC SUCTION PUMP