FDA 510(k)
FDA unclassified
Substantially Equivalent for Some Indications
🇺🇸 United States
BIATAIN FOAM ADHESIVE DRESSING
K Number: K983173
·
Decision Dec 16, 1998
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
54
Review Days
97
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Basic Information
- Device Name
- BIATAIN FOAM ADHESIVE DRESSING
- K Number
- K983173
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Coloplast Corp.
- Date Received
- September 10, 1998
- Decision Date
- December 16, 1998
- Product Code
- FRO
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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