FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERILE CATH CARE KIT
K Number: K821500
·
Decision Jun 23, 1982
Classifications
1
FEI Numbers
323
Registration Numbers
324
Same Product Code
50
Applicant Total
3
Review Days
35
Basic Information
- Device Name
- STERILE CATH CARE KIT
- K Number
- K821500
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- PRO-PAK
- Date Received
- May 19, 1982
- Decision Date
- June 23, 1982
- 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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