510(k) K032242
- Device
- PERSONNA PLUS SAFETY SCALPEL SYSTEM
- Applicant
- OMI MANUFACTURING PTY., LTD.
- 510(k) number
- K032242
- Product code
- GES
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-09-23
- Date received
- 2003-07-21
- 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
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- DANIEL KAMM
- Address
- P.O. Box 7007 Deer Field IL US 60015 60015
FDA Registration Numbers#
- 3005327291
- 3030446844
- 3016674858
- 1315756
- 3002090132
- 3032391
- 8010370
- 3004468256
- 2438391
- 1625425
- 1643817
- 1123010
- 3009495876
- 3003965134
- 8031015
- 3008489813
- 3008392711
- 9680794
- 9680927
- 3045058049
- 8010697
- 1649395
- 3011547157
- 3005061536
- 3008912461
- 3023244395
- 3005787343
- 2523320
- 2530138
- 3009973505
- 3043648115
- 9613079
- 1250045
- 3017910185
- 3013901429
- 2916714
- 3007597038
- 1057946
- 8031525
- 3000268902
- 3015309643
- 3009049852
- 3010123303
- 3033526648
- 3010123256
- 2084346
- 3033589330
- 3048101437
- 3015895045
- 2436986
- 3012421607
- 3005595283
- 1423537
- 2243072
- 3043615454
- 1724474
- 3004001706
- 3008808049
- 2648623
- 3010656982
- 3032953138
- 9610905
- 3003477135
- 3010621964
- 1649518
- 3007478714
- 3010032115
- 3007496191
- 3009578786
- 3005273623
- 3004993527
- 3004899005
- 3018783415
- 1416666
- 3038718579
- 3009703496
- 2936485
- 1450662
- 3010055973
- 3011600579
Source Documents#
Other 510(k) Records For Product Code GES #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K932998 | EASY-ON | Devon Industries, Inc. | 1993-08-18 |
| 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#
summary
FDA Review#
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