FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ELEVATORS-COTTLE,MCKENTY,GOLDMAN,JOSEPH,CONVERSE
K Number: K891894
·
Decision Apr 12, 1989
Classifications
1
FEI Numbers
223
Registration Numbers
223
Same Product Code
11
Applicant Total
76
Review Days
19
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Basic Information
- Device Name
- ELEVATORS-COTTLE,MCKENTY,GOLDMAN,JOSEPH,CONVERSE
- K Number
- K891894
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Zinnanti Surgical Instruments, Inc.
- Date Received
- March 24, 1989
- Decision Date
- April 12, 1989
- Product Code
- GEG
- 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 |
|---|---|---|---|
| GEG | Elevator, Surgical, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEG), ordered by most recent decision date.
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| K926181 | ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY | Dec 17, 1993 | Substantially Equivalent |
| K926016 | NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE | Nov 12, 1993 | Substantially Equivalent |