UNIFLEX
FDA 510(k) clearance K820470 · decided 1982-06-02
Clearance details
- K-number
- K820470
- Device name
- UNIFLEX
- Applicant
- Howmedica Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-02-22
- Decision date
- 1982-06-02
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- NAB
- Device class
- 1
- Regulation number
- 878.4014
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, 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 |
|---|---|---|
| IVALON EXTERNAL SPONGE (K946015) | Ivalon | 1995-02-27 |
| ISOLYER (4X4, 8PLY) (K940755) | Isolyer Co. | 1994-05-02 |
| OMNISORB II, NONWOVEN SPONGE, STERILE AND NON (K931610) | Omni Mfg., Inc. | 1993-06-24 |
| MULTI-TRAUMA DRESSING (K925590) | Gam Industries, Inc. | 1993-04-08 |
| K-BAND AND K-CREPE (K926072) | Parema , Ltd. | 1993-03-19 |
| STERILE GAUZE PADS (K915591) | Eagle Medical, Inc. | 1993-01-27 |
| GAUZE SPONGES (K924650) | Dav-Mar Medical Products, Inc. | 1993-01-11 |
| ABSORBENT PAD -- MODIFICATION (K923602) | Winfield Laboratories, Inc. | 1992-12-07 |
| CLINISORB (K923115) | Hermitage Hospital Products, Inc. | 1992-11-23 |
| COMBINE II WETPROOF PAD (K923116) | Hermitage Hospital Products, Inc. | 1992-10-06 |
| USP TYPE VII GAUZE SPONGES (K923378) | E.W.A., Ltd. | 1992-10-06 |
| BURN DRESSING (K923846) | Medical Action Industries, Inc. | 1992-09-11 |
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 |