FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERILE TRACHEOSTOMY CARE KIT
K Number: K821501
·
Decision Jun 16, 1982
Classifications
1
FEI Numbers
329
Registration Numbers
330
Same Product Code
61
Applicant Total
3
Review Days
28
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Basic Information
- Device Name
- STERILE TRACHEOSTOMY CARE KIT
- K Number
- K821501
- 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 16, 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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