510(k) K760605
- Device
- LIGHTCAST II CARBIDE BLADE
- Applicant
- MERCK, SHARP & DOHME
- 510(k) number
- K760605
- Product code
- GES
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-10-05
- Date received
- 1976-09-08
- 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#
- 3008496560
- 3006982105
- 2431166
- 3008294339
- 1644312
- 8010617
- 8010298
- 9611680
- 1526534
- 3029901632
- 2084346
- 3016438694
- 1720929
- 2245304
- 3003244954
- 1319639
- 3015177648
- 1054241
- 2320762
- 3022862651
- 3044819802
- 8043441
- 3006554788
- 3013421458
- 8022890
- 1828464
- 3002675176
- 1060680
- 3017461134
- 1211998
- 3002714597
- 3003775395
- 3003915875
- 8040263
- 3009889060
- 1250045
- 3007185216
- 3014615697
- 9680889
- 3003477135
- 3004859153
- 8010099
- 3004176895
- 3014314985
- 8010257
- 3010115803
- 3004371426
- 1522875
- 9611367
- 2416465
- 3011642792
- 3039414397
- 2183301
- 3010864832
- 3015895045
- 3007791573
- 3012366928
- 9616088
- 8022032
- 3038718579
- 3010303097
- 3045058049
- 3007887711
- 1054811
- 3002858762
- 1422507
- 3007703436
- 1224960
- 3003537565
- 3008808049
- 8031015
- 1057946
- 3004168759
- 3004450489
- 3007137643
- 3014649053
- 1721676
- 2083544
- 3011600579
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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