UNITED SKIN BARRIER PASTE
FDA 510(k) clearance K844341 · decided 1985-01-18
Clearance details
- K-number
- K844341
- Device name
- UNITED SKIN BARRIER PASTE
- Applicant
- Howmedica Corp.
- Decision
- Substantially Equivalent
- Date received
- 1984-11-08
- Decision date
- 1985-01-18
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- EZR
- Device class
- 1
- Regulation number
- 876.5900
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Ny, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STOMAHESIVE PASTE PROTECTIVE SKIN BARR (K803100) | E. R. Squibb & Sons, Inc. | 1981-01-08 |
| COLO-TAPE (K791146) | Suburban Ostomy Supply Co., Inc. | 1979-07-30 |
| OSTOMY KARAYA GUM POWDER (K761340) | Howmedica Corp. | 1977-03-07 |
| KARAYA GUM POWDER (K770230) | Atlantic Surgical | 1977-02-28 |
| KARAYA GUM PRODUCTS - PROCESS CHANGE (K761319) | Howmedica Corp. | 1977-02-15 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SURGICAL SIMPLEX P BONE CEMENT (N17004/S013) | Howmedica Corp. | 2000-12-15 |
| SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT (N17004/S012) | Howmedica Corp. | 2000-06-20 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S011) | Howmedica Corp. | 1998-03-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S010) | Howmedica Corp. | 1997-11-13 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S009) | Howmedica Corp. | 1997-08-08 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S008) | Howmedica Corp. | 1996-12-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S005) | Howmedica Corp. | 1995-11-21 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S006) | Howmedica Corp. | 1995-02-24 |