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#
- 3010966701
- 3010055973
- 3010131137
- 3010656982
- 3008247695
- 3007185216
- 9616088
- 3012421607
- 3004605321
- 1061124
- 3007703436
- 3004899005
- 3008808049
- 3014649053
- 9611579
- 3039414397
- 1032347
- 9616250
- 3045058049
- 3021023132
- 3033589330
- 1828464
- 1526534
- 3032953138
- 1315756
- 8010370
- 3014023545
- 3008912461
- 2243072
- 3030447506
- 1721676
- 1720929
- 1424263
- 1055236
- 3015974593
- 8010257
- 9615162
- 3003477135
- 9680890
- 3004371426
- 9613079
- 3011137372
- 2936485
- 3009703496
- 3010553238
- 1211998
- 3008294339
- 9611959
- 3004168759
- 2183301
- 3004417597
- 3007496191
- 3016674858
- 3010621964
- 1220246
- 3002675176
- 3011983031
- 1649395
- 2648727
- 3001124136
- 3023244395
- 3006110126
- 3038718579
- 3009889060
- 1825034
- 2436986
- 3002808270
- 3014314985
- 1250045
- 1224960
- 1066741
- 3043615454
- 1036836
- 3031564283
- 3006554788
- 3012366928
- 3015895045
- 3029901632
- 8010329
- 3009513193
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 |
| K863885 | SABLE BLADES | Sable Industries | 1986-10-24 |
| K863867 | DEXTRA DISPOSABLE BLADES | Storz Instrument Co. | 1986-10-24 |
| K863214 | KEISEI MICRO-BLADES (STERILE AND NON-STERILE) | Keisei Medical Industrial Co., Ltd. | 1986-09-02 |
| K863211 | KEISEI SURGICAL BLADES (STERILE & NON-STERILE) | Keisei Medical Industrial Co., Ltd. | 1986-09-02 |
Legacy Summary#
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FDA Review#
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