FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DERMIDRESS
K Number: K844463
·
Decision Jan 8, 1985
Classifications
1
FEI Numbers
972
Registration Numbers
972
Same Product Code
186
Applicant Total
12
Review Days
49
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
- DERMIDRESS
- K Number
- K844463
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Kells Medical, Inc.
- Date Received
- November 20, 1984
- Decision Date
- January 8, 1985
- Product Code
- KGX
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGX), ordered by most recent decision date.
SERAGARD INJECTION PATCH
FDA 510(k)
FDA Class 1
·General Hospital
CARE BAND ANTIBACTERIAL BANDAGES
FDA 510(k)
FDA Class 1
·General Hospital
SYVEK PATCH
FDA 510(k)
FDA Class 1
·General Hospital
ADHESIVE BANDAGES WITH OTC DRUG
FDA 510(k)
FDA Class 1
·General Hospital
TARGETT PATCH
FDA 510(k)
FDA Class 1
·General Hospital
PARALLEL
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Kells Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K926333 | CPR PLUS | Nov 8, 1993 | Substantially Equivalent |
| K890093 | PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SET | Jul 24, 1989 | Substantially Equivalent |
| K890095 | PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET | May 24, 1989 | Substantially Equivalent |
| K890094 | EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET | May 24, 1989 | Substantially Equivalent |
| K861972 | DERMISTRIP | Jun 27, 1986 | Substantially Equivalent for Some Indications |
| K844072 | DERMIZIP SKIN CLOSURE DEVICE | Nov 5, 1984 | Substantially Equivalent |
| K832678 | PHONATORY FUNCTION ANALYZER PS-77 | Mar 7, 1984 | Substantially Equivalent |
| K832667 | LUCAE'S EAR & NASAL APPLICATORS | Sep 29, 1983 | Substantially Equivalent |
| K823118 | SAY | Jan 7, 1983 | Substantially Equivalent |
| K823226 | SN-100 DOCTOR'S ROUND | Nov 22, 1982 | Substantially Equivalent |