FDA 510(k)
FDA class 1
Substantially Equivalent
🇦🇺 Australia
ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR
K Number: K853114
·
Decision Aug 6, 1985
Classifications
1
FEI Numbers
656
Registration Numbers
656
Same Product Code
99
Applicant Total
5
Review Days
13
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Basic Information
- Device Name
- ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR
- K Number
- K853114
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Australian Biomedical Corporation , Ltd.
- Date Received
- July 24, 1985
- Decision Date
- August 6, 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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