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#
- 3002675176
- 3013557562
- 1061124
- 1060680
- 8040263
- 2410251
- 3004899005
- 1032347
- 3007478714
- 3006210673
- 8031525
- 3044819802
- 3010583458
- 2436986
- 3003032798
- 9612278
- 3004993527
- 1420054
- 3009746061
- 1422507
- 1423537
- 3008808049
- 1646747
- 3023443842
- 3019356409
- 2183650
- 3012507533
- 9680889
- 1055236
- 3009217531
- 3015276580
- 3000328994
- 3010692967
- 3013901429
- 2084346
- 9680837
- 3001124136
- 3008770252
- 3011600579
- 1721504
- 2648727
- 3026041755
- 3009513193
- 1054241
- 8010298
- 3014334038
- 3004605321
- 3013466775
- 8010732
- 3005067367
- 3014023545
- 3005273623
- 3004450489
- 8010159
- 2523320
- 3014383302
- 9612086
- 3012366928
- 1211998
- 8010099
- 3015974593
- 1625425
- 3016032497
- 9614636
- 8022032
- 9610612
- 8040573
- 3016844398
- 3010656982
- 3016674858
- 3017461134
- 3011642792
- 3009049852
- 1417592
- 3043226252
- 1649518
- 2438391
- 3003775395
- 1721676
- 1220905
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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