FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
AD-HEAL(TM) WOUND DRESSING
K Number: K881731
·
Decision Aug 31, 1988
Classifications
1
FEI Numbers
502
Registration Numbers
502
Same Product Code
106
Applicant Total
1
Review Days
131
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AD-HEAL(TM) WOUND DRESSING
- K Number
- K881731
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4020
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Nepera, Inc.
- Date Received
- April 22, 1988
- Decision Date
- August 31, 1988
- Product Code
- NAD
- 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 |
|---|---|---|---|
| NAD | Dressing, Wound, Occlusive | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NAD), ordered by most recent decision date.
SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
APLION TOPICAL CARE SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CENTURION SORBAVIEW OTC
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DERMASTREAM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
OXYBAND WOUND DRESSING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery