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#
- 3010187826
- 9680794
- 3017095924
- 3017911818
- 3008384335
- 3016758972
- 3008044484
- 3013496867
- 3042972928
- 3011689956
- 3017107376
- 3006787036
- 3003835287
- 3011103697
- 3033011342
- 3001124136
- 3016426851
- 3013034812
- 3032597249
- 3025028726
- 1030451
- 3013524663
- 3039282838
- 3015989868
- 3009555608
- 2433012
- 3043226252
- 3016050930
- 3015140199
- 3029301588
- 3009542933
- 3019543072
- 3001650535
- 3020460367
- 1319130
- 3019798849
- 3008386507
- 3017633586
- 3031180770
- 2435946
- 2182318
- 1220477
- 1225532
- 9680271
- 3020978033
- 3032857683
- 9611462
- 3011238790
- 3023339256
- 9612354
- 3016450032
- 8030654
- 3038637162
- 3007289408
- 3004704697
- 3005621808
- 3010034780
- 3013523368
- 3005728058
- 3009526454
- 3045857302
- 3022147580
- 3012535730
- 3039394934
- 1000179416
- 3006636956
- 2183416
- 3008298053
- 3015456954
- 3004513970
- 3004014222
- 3011193403
- 3013557562
- 1037007
- 3023809973
- 1211998
- 3022627125
- 2027062
- 3014312726
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 |
| K923116 | COMBINE II WETPROOF PAD | Hermitage Hospital Products, Inc. | 1992-10-06 |
| K923378 | USP TYPE VII GAUZE SPONGES | E.W.A., Ltd. | 1992-10-06 |
| K923846 | BURN DRESSING | Medical Action Industries, Inc. | 1992-09-11 |
| K915821 | MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES | Kerma Medical Products, Inc. | 1992-05-29 |
| K920282 | PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE | Trinity Laboratories, Inc. | 1992-05-29 |
| K920269 | EZ GAUZE SPONGE | Cal West Trading Co. | 1992-04-22 |