FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OLSEN #770 DISPOSABLE HOLSTER
K Number: K820158
·
Decision Feb 5, 1982
Classifications
1
FEI Numbers
231
Registration Numbers
231
Same Product Code
66
Applicant Total
3
Review Days
16
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Basic Information
- Device Name
- OLSEN #770 DISPOSABLE HOLSTER
- K Number
- K820158
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Olsen Electro-Surgical Instruments, Inc.
- Date Received
- January 20, 1982
- Decision Date
- February 5, 1982
- Product Code
- KDC
- 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 |
|---|---|---|---|
| KDC | Instrument, Surgical, Disposable | FDA class 1 | General, Plastic Surgery |
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