FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CK 4900 SERIES, GOWN AND TOWEL PAK
K Number: K874760
·
Decision Dec 10, 1987
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
109
Applicant Total
13
Review Days
21
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Basic Information
- Device Name
- CK 4900 SERIES, GOWN AND TOWEL PAK
- K Number
- K874760
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Currie Medical Specialties, Inc.
- Date Received
- November 19, 1987
- Decision Date
- December 10, 1987
- Product Code
- LRO
- 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 |
|---|---|---|---|
| LRO | General Surgery Tray | FDA class 2 | General, Plastic Surgery |
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