FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUTOMATIC RETRACTOR HOLDER
K Number: K780708
·
Decision Jul 17, 1978
Classifications
1
FEI Numbers
656
Registration Numbers
656
Same Product Code
99
Applicant Total
2
Review Days
83
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AUTOMATIC RETRACTOR HOLDER
- K Number
- K780708
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Great Eastern Lumber Co., Inc.
- Date Received
- April 25, 1978
- Decision Date
- July 17, 1978
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAD), ordered by most recent decision date.
JRP Wound Spreader
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
OTELO LL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DASH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
QUADRANT RETRACTOR SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Great Eastern Lumber Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K780999 | X-RAY FRAME HOLDER | Jun 27, 1978 | Substantially Equivalent |