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 | Device Class | Medical Specialty |
|---|---|---|---|
| FSM | Tray, Surgical, Instrument | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FSM), ordered by most recent decision date.
INSTRUMENT TRAY LINER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SINGLE USE INSTRUMENT TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SURGICAL INSTRUMENT TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ARTHROSCOPY TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
OPEN HEART TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HEART CATH TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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| K Number | Device Name | ||
|---|---|---|---|
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| K073369 | EI DOWNPAK BARRIER SLEEVES | Feb 27, 2008 | Substantially Equivalent |
| K070975 | SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES | Jun 21, 2007 | Substantially Equivalent |
| K053178 | SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS | Feb 1, 2006 | Substantially Equivalent |
| K012060 | MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT | Jul 27, 2001 | Substantially Equivalent |
| K953919 | DENTAL ULTRASONIC SCALER INSERTS | Oct 7, 1995 | Substantially Equivalent |
| K912473 | ACCU-PLACER TM KIT | Jul 24, 1991 | Substantially Equivalent |