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#
- 3003775395
- 3010131137
- 3004122598
- 3013683058
- 1319639
- 3016032497
- 3002808270
- 3015225571
- 3008489813
- 3012366928
- 3012507533
- 1644312
- 1724474
- 3003244954
- 3011642792
- 3011547157
- 2320762
- 3016438694
- 3002858762
- 3036795921
- 3005327291
- 2529846
- 3014023545
- 1066741
- 3004519921
- 9680718
- 3004899005
- 2916714
- 3004135030
- 1828288
- 9615162
- 3004571672
- 3005067367
- 3045058049
- 3034525
- 9611283
- 3013901429
- 3002090132
- 3026041755
- 3017461134
- 3010175289
- 3012002722
- 9680837
- 8043441
- 3013846070
- 3010115803
- 3003537565
- 3021477808
- 8031015
- 3009513193
- 1649518
- 3003965134
- 8010329
- 3033526648
- 1646747
- 3010041511
- 2648623
- 1421879
- 9680222
- 3048101437
- 3022862651
- 3011137372
- 1721504
- 3004417597
- 8010257
- 8010732
- 3008950755
- 3000268902
- 3012421607
- 3010656982
- 9611102
- 1054811
- 3009495876
- 3019356409
- 3002714597
- 2936485
- 3009973505
- 3015974593
- 3016674858
- 9611367
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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