FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HYDRASORB JOYCE SPONGE
K Number: K925841
·
Decision May 12, 1993
Classifications
1
FEI Numbers
500
Registration Numbers
500
Same Product Code
3
Applicant Total
4
Review Days
175
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
- HYDRASORB JOYCE SPONGE
- K Number
- K925841
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4018
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Avitar, Inc.
- Date Received
- November 18, 1992
- Decision Date
- May 12, 1993
- Product Code
- NAC
- 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 |
|---|---|---|---|
| NAC | Dressing, Wound, Hydrophilic | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NAC), ordered by most recent decision date.
DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SORBSAN TOPICAL WOUND DRESSING (MODIFIED)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ALGINATE FIBER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery