510(k) K900266
- Device
- Sterile Carbon Steel Surgical Blade
- Applicant
- RAHN LABORATORIES
- 510(k) number
- K900266
- Product code
- GES
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-03-01
- Date received
- 1990-01-18
- 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#
- Contact
- RANDAL J KIRK
- Address
- P.O. Box 126 Bland VA US 24315 24315
FDA Registration Numbers#
- 3015173212
- 3013901429
- 1423537
- 3014383302
- 2410251
- 9610612
- 8010617
- 3016844398
- 8043441
- 9680837
- 3014334038
- 9680927
- 3006389770
- 8010704
- 3011642792
- 1423662
- 3010966701
- 3004971305
- 9611579
- 3015974593
- 3006897996
- 9616250
- 8010370
- 2431166
- 1416666
- 3019387954
- 1625425
- 3005787343
- 3019356409
- 8010159
- 2438391
- 3036795921
- 9680890
- 2648623
- 3010303097
- 3015177648
- 3004899005
- 1420054
- 3043615454
- 9613910
- 3005067367
- 2936485
- 3002714597
- 9616088
- 9611194
- 3009968482
- 3009049852
- 3015895045
- 3009973505
- 3043648115
- 3004371426
- 1319639
- 3004608878
- 2436986
- 1054241
- 2245304
- 1123010
- 9680143
- 3002808270
- 9615162
- 3012366928
- 3007703436
- 3003915875
- 3009703496
- 3007791573
- 3010032115
- 3014314985
- 3017367014
- 1422507
- 3021023132
- 9680411
- 3004001706
- 3000268902
- 3003759558
- 3016763307
- 1032347
- 9611102
- 3004417597
- 9611665
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 |
| 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 |
| K855104 | ANGIOMED SKIN FASCIA KNIFE | Angiomed U.S., Inc. | 1986-01-24 |