510(k) K834142
- Device
- ADHESIVE TRACTION TAPE
- Applicant
- DEVON INDUSTRIES, INC.
- 510(k) number
- K834142
- Product code
- GAD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-04-23
- Date received
- 1983-12-01
- Regulation
- 878.4800
- Classification name
- Retractor
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3043355002
- 3022862651
- 3004571672
- 3007648354
- 3013497507
- 8040884
- 8043404
- 1926681
- 1834379
- 8044098
- 3004142400
- 3003803182
- 3005813597
- 9615005
- 9612420
- 3015212339
- 3010531060
- 3003418325
- 3012226300
- 3035678069
- 1720747
- 3014763043
- 8010298
- 3000931034
- 3008280196
- 9611062
- 3017565094
- 9616250
- 3005440795
- 8010300
- 1649379
- 3005031160
- 2648988
- 8040278
- 3012120772
- 3010197239
- 3010370500
- 3023191945
- 3010123256
- 3007407626
- 8010877
- 1723241
- 9680519
- 8010890
- 8010155
- 3006946279
- 3036795921
- 3004598675
- 3008132398
- 3005180920
- 3004371426
- 3014003062
- 3009513193
- 3012267976
- 9610621
- 3015399803
- 9614093
- 2648623
- 9613926
- 2249529
- 3031240334
- 9614945
- 3035111096
- 3030412764
- 3004111573
- 3009865268
- 3001084743
- 3008650117
- 3000286616
- 3008497357
- 3012995405
- 1058726
- 3006169466
- 3008693678
- 3010123206
- 1058020
- 8031020
- 2648727
- 3017521423
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GAD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K152538 | JRP Wound Spreader | J.R. Parker, LLC | 2016-04-13 |
| K151104 | OTELO LL | Spineart | 2016-01-06 |
| K132645 | THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES | Medtronic, Inc. | 2013-10-04 |
| K071775 | DASH | Ezsurgical | 2007-08-07 |
| K050256 | APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR | Apple Medical Corp. | 2005-04-26 |
| K043602 | QUADRANT RETRACTOR SYSTEM | Medtronic Sofamor Danek | 2005-02-23 |
| K001339 | MRI FASTSYSTEM RETRACTOR SYSTEM | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | 2000-05-17 |
| K980588 | CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 | Clarus Medical Systems, Inc. | 1998-08-18 |
| K963006 | SCION SAPHENOUS VEIN HARVESTING SYSTEM | Scion International, Inc. | 1996-09-20 |
| K943875 | VILLALTA RETRACTOR | Hct, Inc. | 1994-11-09 |
| K942002 | RETRACTOR | Automated Medical Products Corp. | 1994-05-17 |
| K941448 | RETRACTOR | Technovations | 1994-04-15 |
| K930316 | LUNG RETRACTORS: DAVIDSON, SEMB | Thomasville Medical Assoc. | 1994-02-10 |
| K926585 | THOROCOSCOPY SELF-RETAINING RETRACTOR | T. Korossurgical Instruments Corp. | 1993-08-06 |
| K921017 | HARGIS SR2 SELF-RETRACTION SYSTEM | Medin Corp. | 1993-07-02 |
Legacy Summary#
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FDA Review#
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