FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR SU
K Number: K864115
·
Decision Nov 7, 1986
Classifications
1
FEI Numbers
214
Registration Numbers
214
Same Product Code
28
Applicant Total
3
Review Days
28
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Basic Information
- Device Name
- TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR SU
- K Number
- K864115
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Cathaid, Inc.
- Date Received
- October 10, 1986
- Decision Date
- November 7, 1986
- Product Code
- KGZ
- 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 |
|---|---|---|---|
| KGZ | Accessories, Catheter | FDA class 1 | General, Plastic Surgery |
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