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

INTELIJET SUCTION SUPPLY

K Number: K922176 · Decision Nov 18, 1992
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
158
Applicant Total
22
Review Days
194

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Basic Information

Device Name
INTELIJET SUCTION SUPPLY
K Number
K922176
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4780
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Smith & Nephew Dyonics, Inc.
Date Received
May 8, 1992
Decision Date
November 18, 1992
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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K936071 SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE
K934299 DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION
K920267 DYONICS ARTHROSCOPIC KIT
K914963 SMITH & NEPHEW DYONICS TMJ ARTHROSCOPY INFLOW SET
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