510(k) K932998
- Device
- EASY-ON
- Applicant
- DEVON INDUSTRIES, INC.
- 510(k) number
- K932998
- Product code
- GES
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-08-18
- Date received
- 1993-06-18
- Regulation
- 878.4800
- Classification name
- Blade, Scalpel
- 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
- RUDY GABA
- Address
- 9530 De Soto Ave. Chatsworth CA US 91311 91311
FDA Registration Numbers#
- 3010032115
- 3012366928
- 2083544
- 3008812251
- 3013557562
- 3005273623
- 9612086
- 3004082121
- 3005327291
- 8010099
- 3034525
- 8010617
- 3010583458
- 3004168759
- 1423662
- 1036836
- 3006554788
- 9614157
- 3012507533
- 2436986
- 3012002722
- 3009889060
- 3008770252
- 2183650
- 9611680
- 8043441
- 3002858762
- 1522875
- 3007389672
- 3003537565
- 8010697
- 3019387954
- 3010123256
- 3005440795
- 3016438694
- 3015726551
- 3021477808
- 2416465
- 9611102
- 9611283
- 3006210673
- 9680837
- 3011983031
- 9680718
- 1220905
- 3015309643
- 3023443842
- 2438391
- 3006389770
- 3006982105
- 1836161
- 1649395
- 9612278
- 3003775395
- 3010175289
- 2320762
- 3008392711
- 3006950086
- 1423395
- 1250045
- 3015140199
- 3004993527
- 3015974593
- 2648623
- 2649798
- 3021023132
- 1825034
- 3023244395
- 3015225571
- 8010370
- 3026041755
- 3016763307
- 2410251
- 3032953138
- 3010692967
- 1224960
- 1420054
- 3006110126
- 3005061536
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GES #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K032242 | PERSONNA PLUS SAFETY SCALPEL SYSTEM | Omi Manufacturing Pty., Ltd. | 2003-09-23 |
| K923170 | LOS ALAMOS RETRACTABLE KNIFE | Innovative Surgical Technology, Inc. | 1993-02-18 |
| K915119 | SCALPEL BLADE REMOVER (BLADEGARD) | Intergrated Visual, Inc. | 1992-05-05 |
| K911913 | PRECISION GLIDE - ENHANCED SURGICAL BLADE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-05-13 |
| K900266 | STERILE CARBON STEEL SURGICAL BLADE | Rahn Laboratories | 1990-03-01 |
| K884862 | ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE | Anchor Products Co. | 1988-12-27 |
| K881638 | SURGICAL BLADE | Far East Intl. Trading Corp. | 1988-06-15 |
| K880244 | SURGICAL BLADES | Ailee C/O Havel'S, Inc. | 1988-02-10 |
| K873493 | NINJA SCALPEL | Primrose Medical, Inc. | 1987-09-24 |
| K873142 | PERSONNA DISPOSABLE SCALPEL | American Safety Razor Co. | 1987-09-04 |
| K863867 | DEXTRA DISPOSABLE BLADES | Storz Instrument Co. | 1986-10-24 |
| K863885 | SABLE BLADES | Sable Industries | 1986-10-24 |
| K863211 | KEISEI SURGICAL BLADES (STERILE & NON-STERILE) | Keisei Medical Industrial Co., Ltd. | 1986-09-02 |
| K863214 | KEISEI MICRO-BLADES (STERILE AND NON-STERILE) | Keisei Medical Industrial Co., Ltd. | 1986-09-02 |
| K855104 | ANGIOMED SKIN FASCIA KNIFE | Angiomed U.S., Inc. | 1986-01-24 |
Legacy Summary#
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FDA Review#
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