510(k) K102403
- Device
- SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL
- Applicant
- SAM MEDICAL PRODUCTS
- 510(k) number
- K102403
- Product code
- NAD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-03-03
- Date received
- 2010-08-24
- Regulation
- 878.4020
- Classification name
- Dressing, Wound, Occlusive
- 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
- JACK N MCCUTCHEON
- Address
- 27350 SW 95th Ave. Suite 3038 Bldg. 30 Wilsonville OR US 97070 97070
FDA Registration Numbers#
- 1123137
- 3022568093
- 3017846547
- 3015821396
- 3042277868
- 3035767957
- 3009057691
- 3015414875
- 3018507299
- 1060680
- 3016159364
- 3011582224
- 3005034064
- 9611024
- 3004022422
- 3026331889
- 3006802076
- 3010131137
- 2939142
- 3004102812
- 3030087693
- 3013122778
- 3005735974
- 1043549
- 3004270595
- 3042283853
- 1930027
- 3007187674
- 1287317
- 3003965134
- 3003636207
- 3032327991
- 2530957
- 3009039068
- 2183416
- 3029971427
- 3017036472
- 3005858760
- 3011191255
- 9610694
- 3017396949
- 3012441818
- 3015341499
- 3038988287
- 3021082429
- 3015058854
- 9710608
- 3003835287
- 3015140210
- 1720929
- 3009486864
- 3011715978
- 1034876
- 3015781786
- 3010546717
- 3013354376
- 3010165567
- 3009562494
- 3025771169
- 3013557562
- 3011689956
- 3034604687
- 3023339256
- 3009109670
- 1119193
- 1000119796
- 3004857344
- 3014747754
- 1417592
- 1018120
- 3009882464
- 3008392711
- 3023191945
- 3009640188
- 3013510154
- 9680198
- 1038963
- 3006371704
- 3039775399
Source Documents#
Other 510(k) Records For Product Code NAD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K091133 | APLION TOPICAL CARE SYSTEM | Aplion Medical,Llc | 2009-05-20 |
| K072560 | ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) | Teikoku Pharma USA, Inc. | 2008-06-17 |
| K080524 | CENTURION SORBAVIEW OTC | Tri-State Hospital Supply Corp. | 2008-04-23 |
| K060046 | DERMASTREAM | Enzysurge , Ltd. | 2006-02-27 |
| K043063 | OXYBAND WOUND DRESSING | Oxyband Technologies, Inc. | 2005-03-24 |
| K020781 | WET CHAMBER | Kinetic Concepts, Inc. | 2002-05-06 |
| K990530 | KERLIX MD ANTIMICROBIAL GAUZE DRESSING | The Kendall Company, L.P. | 2000-01-31 |
| K990861 | WOUND DRESSING/ABD PAD, MODEL #10810 | Hospital Specialty Co. | 1999-04-12 |
| K964534 | OTOSILK OTOLOGICAL GRAFT DRESSING | Boston Medical Products, Inc. | 1997-04-09 |
| K960815 | DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL | Dumex Medical Surgical Products, Ltd. | 1996-04-29 |
| K955863 | ALLDRESS MULTI LAYERED WOUND DRESSING | Molnlycke/Scott Health Care | 1996-03-13 |
| K952203 | OTOSILK | Boston Medical Products, Inc. | 1995-07-31 |
| K930697 | MEDLINE STERILE GAUZE SPONGES | Medline Industries, Inc. | 1993-06-24 |
| K912022 | FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES | Fraass Survival Systems, Inc. | 1991-08-02 |
| K905519 | MONTROSE DRESSING APPLICATORS | Olemunda Pty , Ltd. | 1991-03-06 |
Legacy Summary#
summary
FDA Review#
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