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#
- 3007187674
- 3016674858
- 3017264244
- 3017846547
- 3029971427
- 3036035308
- 3010805190
- 3003767891
- 3030333982
- 3006506075
- 2648727
- 3011881316
- 3010512490
- 3010419931
- 3008244559
- 3017220525
- 1119193
- 3039775399
- 3016769192
- 3008559295
- 3007841320
- 3014666579
- 3008676146
- 3030067857
- 9710583
- 3022568093
- 3015378469
- 3009344179
- 3014314985
- 3030394731
- 3042198580
- 3011210302
- 3013524663
- 3007289408
- 3027977504
- 3025413691
- 3002806603
- 3004176951
- 2135339
- 3043503913
- 3007360701
- 3010132111
- 3004869142
- 3014584671
- 3006621348
- 1043214
- 3015375647
- 3011280379
- 3034618336
- 1061927
- 3008808082
- 3031757047
- 3010034780
- 3009109670
- 3005030934
- 3010339057
- 3008386507
- 3010957766
- 1038758
- 1720929
- 3015276780
- 3013526501
- 3021032023
- 3006538822
- 3013872035
- 1646434
- 1423662
- 3019604572
- 3015142802
- 3014312726
- 8043396
- 3014437893
- 1528440
- 3015168783
- 8032044
- 3005004019
- 3015946389
- 3017036472
- 3004681519
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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