FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
CUSTOM CV PACK
K Number: K936255
·
Decision Mar 31, 1994
Classifications
1
FEI Numbers
329
Registration Numbers
330
Same Product Code
61
Applicant Total
3
Review Days
91
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Basic Information
- Device Name
- CUSTOM CV PACK
- K Number
- K936255
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Associated Medical
- Date Received
- December 30, 1993
- Decision Date
- March 31, 1994
- Product Code
- KDD
- 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 |
|---|---|---|---|
| KDD | Kit, Surgical Instrument, Disposable | FDA class 1 | General, Plastic Surgery |
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