510(k) K964534
- Device
- OTOSILK OTOLOGICAL GRAFT DRESSING
- Applicant
- BOSTON MEDICAL PRODUCTS, INC.
- 510(k) number
- K964534
- Product code
- NAD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-04-09
- Date received
- 1996-11-12
- 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
- STUART K MONTGOMERY
- Address
- 117 Flanders Rd. Westborough MA US 01581 01581
FDA Registration Numbers#
- 3011715978
- 3003799320
- 3010305275
- 3012034017
- 3034669683
- 1000317571
- 3013034812
- 1047843
- 3011862887
- 1038758
- 3003835287
- 3017235663
- 9680143
- 3030333982
- 3019804885
- 3014421917
- 3021282544
- 3005735974
- 3009039068
- 3010785927
- 3008264111
- 3007417776
- 3012441818
- 2951555
- 3009167225
- 3030067857
- 1055236
- 3012777736
- 3010034780
- 3007307589
- 3005841027
- 2135152
- 3035523371
- 3011582224
- 3008958609
- 3015276780
- 9614157
- 3017264244
- 3003965134
- 9616872
- 3010824458
- 3010512490
- 3044777107
- 3008076203
- 1644312
- 3011307048
- 3021630959
- 3038200636
- 9710020
- 9616088
- 1018233
- 1054241
- 3006371704
- 3004022422
- 3005460813
- 1043549
- 1420763
- 3008485841
- 3007966889
- 1319639
- 3005858760
- 3008676146
- 3017846547
- 3002807310
- 3011089435
- 3004869142
- 3003807757
- 3011707784
- 3009171251
- 3008502431
- 8010485
- 3014368824
- 3034605486
- 3025430561
- 3006358042
- 1000118068
- 3044026004
- 2135339
- 3018116884
Source Documents#
Other 510(k) Records For Product Code NAD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K102403 | SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL | Sam Medical Products | 2011-03-03 |
| 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 |
| 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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