510(k) K914604
- Device
- Mepitel Non-adherent Silicone Dressing
- Applicant
- MOLNLYCKE CLINICAL PRODUCTS AB
- 510(k) number
- K914604
- Product code
- NAB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-03-25
- Date received
- 1991-10-17
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- SVEN E SIEVERS
- Address
- C/O Swedish Trade Council 150 N. Michigan Ave., Suite 1200 Chicago IL US 60601 60601
FDA Registration Numbers#
- 3015821396
- 3011193403
- 2245304
- 3015414875
- 1060680
- 3027605727
- 3005034064
- 3017910185
- 3024891479
- 9611024
- 3002722429
- 3026331889
- 3011564291
- 3039394934
- 1000115322
- 1020279
- 3014819517
- 3016733683
- 9613793
- 3010131137
- 3015173212
- 3025414363
- 3008044484
- 3022147580
- 3004519921
- 3012268821
- 3010220595
- 9611459
- 3030133968
- 3013122778
- 3005735974
- 3023323193
- 3042283853
- 3009470597
- 3007187674
- 3014925393
- 3003965134
- 3010951384
- 3005024024
- 3003636207
- 2530957
- 9680271
- 1313700
- 3010380285
- 2183416
- 3011191255
- 3025384290
- 3004998166
- 3013632692
- 3003915875
- 3002801783
- 3015058854
- 3003835287
- 3009486864
- 3011279497
- 3015781786
- 3010967704
- 3009562494
- 3004617181
- 3005012805
- 9612051
- 3004967902
- 3013557562
- 3011689956
- 3011983031
- 3043106338
- 3023339256
- 3013530901
- 3013547614
- 3000256895
- 1417592
- 1018120
- 3008392711
- 3023191945
- 3022954003
- 3016457665
- 3011310668
- 3021023132
- 3023809973
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K921227 | TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE | Courtaulds Fibers, Inc. | 1992-05-29 |
| 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 |