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#
- 3010700223
- 3017079526
- 3035744034
- 3016816754
- 3035523371
- 3015745029
- 3008044603
- 3005951296
- 3004135030
- 3010380285
- 3016758972
- 3013226
- 9680934
- 3010872396
- 3013188547
- 3009403363
- 3009470597
- 3009486864
- 3013523368
- 3004753358
- 2027062
- 9611959
- 3041329419
- 3038131023
- 3005202235
- 3015214015
- 3031582449
- 9680222
- 3003675658
- 3026263452
- 3010621964
- 3038637162
- 1060680
- 3013632692
- 3023191945
- 3035642068
- 3006517436
- 3009555608
- 3014683120
- 3007407626
- 3007327603
- 3017461134
- 3045816902
- 3015379055
- 3013919644
- 3014312726
- 3008132398
- 2530957
- 3011707926
- 3002468342
- 3012084379
- 1211998
- 3017870985
- 3000126234
- 3008559238
- 3008485841
- 3010383831
- 1043572
- 3008374791
- 3031582434
- 3030394731
- 1000115322
- 3004551550
- 1219071
- 3023141635
- 1420763
- 3004967902
- 3005012805
- 3010610950
- 3007480628
- 3011816517
- 3008496560
- 3042032212
- 3042953785
- 3005761322
- 3015997711
- 3030067857
- 3004569180
- 3017248120
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 |