FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UNITED SKIN BARRIER
K Number: K770982
·
Decision Jul 15, 1977
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
2
Applicant Total
373
Review Days
45
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Basic Information
- Device Name
- UNITED SKIN BARRIER
- K Number
- K770982
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5900
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Howmedica Corp.
- Date Received
- May 31, 1977
- Decision Date
- July 15, 1977
- Product Code
- EXE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| EXE | Protector, Ostomy | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EXE), ordered by most recent decision date.
CONVATEC ABSORBENT BANDAGE
FDA 510(k)
FDA Class 1
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STOMA SHIELD ADAPTER
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Other Clearances by Howmedica Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K983528 | MICRO DYNAMIC MESH | Dec 23, 1998 | Substantially Equivalent |
| K983404 | TYPE 3 FEMORAL COMPONENTS | Dec 22, 1998 | Substantially Equivalent |
| K980925 | DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION | Dec 16, 1998 | Substantially Equivalent |
| K980926 | DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION | Dec 16, 1998 | Substantially Equivalent |
| K980632 | DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION | Dec 11, 1998 | Substantially Equivalent |
| K980626 | DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION | Dec 11, 1998 | Substantially Equivalent |
| K983419 | HOFFMANN II MIAMI POST | Nov 25, 1998 | Substantially Equivalent |
| K982958 | ZETA MULTIZONE LOCKING NAIL SYSTEM | Nov 20, 1998 | Substantially Equivalent |
| K982873 | ZETA MULTIZONE SCN LOCKING NAIL | Oct 21, 1998 | Substantially Equivalent |
| K982531 | HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM | Oct 16, 1998 | Substantially Equivalent |