FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

HU-FRIEDY IMS CASSETTE SYSTEM

K Number: K844002 · Decision Nov 8, 1984
Classifications
1
FEI Numbers
875
Registration Numbers
875
Same Product Code
75
Applicant Total
8
Review Days
27

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Basic Information

Device Name
HU-FRIEDY IMS CASSETTE SYSTEM
K Number
K844002
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4800
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Hu-Friedy Mfg. Co., Inc.
Date Received
October 12, 1984
Decision Date
November 8, 1984
Product Code
FSM
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
RA
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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K070975 SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES
K053178 SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS
K012060 MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT
K953919 DENTAL ULTRASONIC SCALER INSERTS
K912473 ACCU-PLACER TM KIT