FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRACHESTOMY & NASAL SUCTIONING KIT #-
K Number: K830711
·
Decision May 2, 1983
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
23
Applicant Total
1
Review Days
56
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Basic Information
- Device Name
- TRACHESTOMY & NASAL SUCTIONING KIT #-
- K Number
- K830711
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Intertex Medical
- Date Received
- March 7, 1983
- Decision Date
- May 2, 1983
- Product Code
- GBZ
- 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 |
|---|---|---|---|
| GBZ | Catheter, Cholangiography | FDA class 1 | General, Plastic Surgery |
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