FDA 510(k)
FDA unclassified
Substantially Equivalent for Some Indications
🇺🇸 United States
MODIFIED HERCON ANTISEPTIC TRANSPARENT DRESSING
K Number: K871255
·
Decision May 29, 1987
Classifications
1
FEI Numbers
402
Registration Numbers
403
Same Product Code
861
Applicant Total
3
Review Days
59
Basic Information
- Device Name
- MODIFIED HERCON ANTISEPTIC TRANSPARENT DRESSING
- K Number
- K871255
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- HERCON LABORATORIES CORP.
- Date Received
- March 31, 1987
- Decision Date
- May 29, 1987
- 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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