FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET
K Number: K903969
·
Decision Sep 5, 1990
Classifications
1
FEI Numbers
656
Registration Numbers
656
Same Product Code
99
Applicant Total
17
Review Days
8
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Basic Information
- Device Name
- SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET
- K Number
- K903969
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Karlin Technology, Inc.
- Date Received
- August 28, 1990
- Decision Date
- September 5, 1990
- Product Code
- GAD
- 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 |
|---|---|---|---|
| GAD | Retractor | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Karlin Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K893201 | BONE PLATE | Apr 4, 1990 | Substantially Equivalent |
| K893203 | BONE SCREW | Apr 4, 1990 | Substantially Equivalent |
| K882525 | SPINAL MICROKNIFE | Sep 22, 1988 | Substantially Equivalent |
| K882519 | X-RAY MARKER | Aug 9, 1988 | Substantially Equivalent |
| K882520 | SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADS | Jul 18, 1988 | Substantially Equivalent |
| K882073 | SPINAL NEEDLE | Jul 18, 1988 | Substantially Equivalent |
| K882524 | UNIVERSALLY ADJUSTABLE ARMBOARD | Jul 8, 1988 | Substantially Equivalent |
| K882069 | SPINAL DISTRACTORS, SPANNERS | Jun 17, 1988 | Substantially Equivalent |
| K882072 | ORTHOPAEDIC AND SPINAL RING CURRETTES | Jun 17, 1988 | Substantially Equivalent |
| K882077 | MICRODISCECTOMY CURRETTES | Jun 17, 1988 | Substantially Equivalent |