FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ITIMIZED INSTRUMENTS
K Number: K790491
·
Decision Apr 4, 1979
Classifications
1
FEI Numbers
251
Registration Numbers
251
Same Product Code
51
Applicant Total
21
Review Days
27
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Basic Information
- Device Name
- ITIMIZED INSTRUMENTS
- K Number
- K790491
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- E.M. Adams
- Date Received
- March 8, 1979
- Decision Date
- April 4, 1979
- Product Code
- FZT
- 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 | Device Class | Medical Specialty |
|---|---|---|---|
| FZT | Cutter, Surgical | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FZT), ordered by most recent decision date.
SMARTSHEARS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
AUTO SUTURE DISPOSABLE SURGICAL TROCAR*
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MICRINS SURGICAL SCISSOR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SINGLE HAIR TRANSPLANT GRAFT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SPC DISPOSABLE CUTTER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SCISSORS, VARIOUS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by E.M. Adams
| K Number | Device Name | ||
|---|---|---|---|
| K905173 | SPLASH GUARD | Apr 25, 1991 | Substantially Equivalent |
| K910468 | STERILE DISPOSABLE DRAPE(S) | Mar 21, 1991 | Substantially Equivalent |
| K873978 | DISPOSABLE BIPOLAR FORCEPS | Nov 23, 1987 | Substantially Equivalent |
| K850063 | INSTRUMENT POCKET | Feb 21, 1985 | Substantially Equivalent |
| K843724 | I.V. START KIT & OBSTETRICAL KIT | Jan 10, 1985 | Substantially Equivalent |
| K843783 | WET PACK | Dec 19, 1984 | Substantially Equivalent |
| K843782 | DRY TRAY | Dec 13, 1984 | Substantially Equivalent |
| K843723 | STERILE INSTRUMENT TRAYS-VARIOUS | Oct 23, 1984 | Substantially Equivalent |
| K843115 | STERILE SOLUTION BOWL | Sep 7, 1984 | Substantially Equivalent |
| K843116 | DISPOSABLE SKIN MARKING PEN | Aug 17, 1984 | Substantially Equivalent |