FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RAYLOR RETRACTORS
K Number: K853796
·
Decision Oct 7, 1985
Classifications
1
FEI Numbers
658
Registration Numbers
658
Same Product Code
99
Applicant Total
17
Review Days
26
Basic Information
- Device Name
- RAYLOR RETRACTORS
- K Number
- K853796
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- CEDAR SURGICAL, INC.
- Date Received
- September 11, 1985
- Decision Date
- October 7, 1985
- 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 CEDAR SURGICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K873692 | RAYLOR(TM) DRILL STOP | Dec 17, 1987 | Substantially Equivalent |
| K872281 | RAYLOR FUSION FUNNEL | Nov 2, 1987 | Substantially Equivalent |
| K873690 | CEDAR(TM) PELVIC CUSHION | Oct 26, 1987 | Substantially Equivalent |
| K873691 | CEDAR(TM) RETRACTOR RING | Sep 28, 1987 | Substantially Equivalent |
| K864425 | RAYLOR(TM) DISSECTING HOOK | Dec 12, 1986 | Substantially Equivalent |
| K864421 | RAYLOR(TM) PERIOSTEAL ELEVATORS | Nov 26, 1986 | Substantially Equivalent |
| K864426 | RAYLOR(TM) DEPTH GAUGE | Nov 26, 1986 | Substantially Equivalent |
| K864424 | RAYLOR(TM) PROTECTIVE RETRACTOR | Nov 26, 1986 | Substantially Equivalent |
| K864423 | RAYLOR(TM) OSTEOTOMES | Nov 24, 1986 | Substantially Equivalent |
| K864422 | RAYLOR(TM) MALLET | Nov 24, 1986 | Substantially Equivalent |