510(k) K921227
- Device
- Tencel Topical Wound Dressing/surgical Sponge
- Applicant
- COURTAULDS FIBERS, INC.
- 510(k) number
- K921227
- Product code
- NAB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-05-29
- Date received
- 1992-03-13
- Regulation
- 878.4014
- Classification name
- Gauze / Sponge,Nonresorbable For External Use
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT FEIL
- Address
- P.O. Box 141 Axis AL US 36505 36505
FDA Registration Numbers#
- 9681385
- 3003062321
- 3007865243
- 1423537
- 3017297225
- 3003674698
- 3006538822
- 3012535730
- 1222313
- 3034669683
- 3027605727
- 3007299770
- 3014257280
- 1423395
- 3010147274
- 3023323193
- 3017417635
- 9616572
- 1052728
- 3015997711
- 3022627125
- 8021899
- 9613910
- 1018120
- 8030128
- 1047843
- 2433012
- 3015895045
- 3011849720
- 1054241
- 3038274448
- 2245304
- 1928237
- 1221254
- 3008770655
- 3016452400
- 3005558160
- 3017633586
- 3020188747
- 1528440
- 8043782
- 9611959
- 1220477
- 3033858895
- 3021286079
- 3006123105
- 1121142
- 1422598
- 3025413691
- 1037007
- 3022147580
- 3017949824
- 3008386507
- 3023339277
- 3030896267
- 9612051
- 3006400320
- 3010864832
- 9680271
- 3008851420
- 3009605026
- 3007344957
- 3015416207
- 3013960199
- 3033451996
- 3012309743
- 3008489813
- 1822565
- 3011279497
- 3004911384
- 1061124
- 3017079526
- 3018228713
- 3010275504
- 1038758
- 3014368824
- 3017220525
- 9612354
- 3015821396
Source Documents#
Other 510(k) Records For Product Code NAB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K946015 | IVALON EXTERNAL SPONGE | Ivalon | 1995-02-27 |
| K940755 | ISOLYER (4X4, 8PLY) | Isolyer Co. | 1994-05-02 |
| K931610 | OMNISORB II, NONWOVEN SPONGE, STERILE AND NON | Omni Mfg., Inc. | 1993-06-24 |
| K925590 | MULTI-TRAUMA DRESSING | Gam Industries, Inc. | 1993-04-08 |
| K926072 | K-BAND AND K-CREPE | Parema , Ltd. | 1993-03-19 |
| K915591 | STERILE GAUZE PADS | Eagle Medical, Inc. | 1993-01-27 |
| K924650 | GAUZE SPONGES | Dav-Mar Medical Products, Inc. | 1993-01-11 |
| K923602 | ABSORBENT PAD -- MODIFICATION | Winfield Laboratories, Inc. | 1992-12-07 |
| K923115 | CLINISORB | Hermitage Hospital Products, Inc. | 1992-11-23 |
| K923378 | USP TYPE VII GAUZE SPONGES | E.W.A., Ltd. | 1992-10-06 |
| K923116 | COMBINE II WETPROOF PAD | Hermitage Hospital Products, Inc. | 1992-10-06 |
| K923846 | BURN DRESSING | Medical Action Industries, Inc. | 1992-09-11 |
| K920282 | PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE | Trinity Laboratories, Inc. | 1992-05-29 |
| K915821 | MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES | Kerma Medical Products, Inc. | 1992-05-29 |
| K920269 | EZ GAUZE SPONGE | Cal West Trading Co. | 1992-04-22 |