510(k) K770800
- Device
- HANDLES, BLADE, SURGICAL
- Applicant
- LUKENS CORP.
- 510(k) number
- K770800
- Product code
- GES
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-05-06
- Date received
- 1977-05-02
- Regulation
- 878.4800
- Classification name
- Blade, Scalpel
- 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#
- 3015974593
- 8022032
- 8040573
- 3008392711
- 3004971305
- 1319639
- 3003537565
- 3036795921
- 3018783415
- 3040389290
- 9611194
- 1051526
- 1421879
- 3008247695
- 1423537
- 3000268902
- 3030019171
- 9680794
- 3003418325
- 2084346
- 3006110126
- 3011600579
- 3032953138
- 1061124
- 3043615454
- 3006950086
- 8010298
- 3016170492
- 3006210673
- 9616088
- 3004111573
- 3002808270
- 3012507533
- 9611680
- 3008489813
- 3011547157
- 3004417597
- 8031015
- 8043441
- 1220246
- 2183301
- 3012536737
- 9611102
- 1720929
- 3007597038
- 1526534
- 3012494290
- 8031525
- 1828288
- 3023443842
- 3010656982
- 2080222
- 3013557562
- 3002675176
- 3030446844
- 3004608878
- 3029082594
- 3015173212
- 3010864832
- 2320762
- 3002808145
- 2242450
- 9680411
- 8040263
- 9680927
- 3035678069
- 9612086
- 3010032115
- 3000328994
- 3009049852
- 3016438694
- 3003244954
- 3008912461
- 3010621964
- 8010099
- 3009513193
- 3038718579
- 3004176895
- 3001124136
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 |
| 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 |
Legacy Summary#
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FDA Review#
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