510(k) K112400
- Device
- SMARTSHEARS
- Applicant
- NUSCIENCE CONSULTING AND MANAGEMENT GROUP, LLC
- 510(k) number
- K112400
- Product code
- FZT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-09-12
- Date received
- 2011-08-19
- Regulation
- 878.4800
- Classification name
- Cutter, Surgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- NIKOLE GOLDSMITH
- Address
- P.O. Box 8507 Fleming Island FL US 32006 32006
FDA Registration Numbers#
- 1423537
- 2029447
- 2029275
- 3015451162
- 3005813597
- 8010769
- 3019455
- 2183449
- 8010617
- 3009662572
- 9610612
- 2242352
- 1219518
- 3009747810
- 3014334038
- 3017231740
- 9611579
- 1057421
- 3001297506
- 8043496
- 9616250
- 3025436467
- 2431166
- 9611813
- 3005980667
- 1416666
- 3005809810
- 8043752
- 8010159
- 3010287737
- 3036795921
- 3009255580
- 3015060238
- 1055890
- 9680518
- 3005067367
- 9616088
- 9611194
- 3009971621
- 3018094310
- 1421101
- 3015895045
- 3030671632
- 1833824
- 9681540
- 3004608878
- 3007344102
- 1054241
- 2245304
- 3013875765
- 1123010
- 3012366928
- 3014725904
- 3010097171
- 9680260
- 3004001706
- 3011706110
- 2246990
- 3015170223
- 1032347
- 9611502
- 9710629
- 5906
- 1057425
- 9710524
- 8021788
- 3016069968
- 3006460162
- 1220477
- 1923569
- 3011530718
- 3005061536
- 8040179
- 3010455030
- 3008812560
- 9611112
- 3012501675
- 8043507
- 2511556
Source Documents#
Other 510(k) Records For Product Code FZT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K890818 | AUTO SUTURE DISPOSABLE SURGICAL TROCAR* | United States Surgical, A Division of Tyco Healthc | 1989-05-04 |
| K872990 | MICRINS SURGICAL SCISSOR | Micrins Surgical, Inc. | 1987-08-17 |
| K841741 | SINGLE HAIR TRANSPLANT GRAFT | Paris Products, Inc. | 1984-07-23 |
| K841247 | SPC DISPOSABLE CUTTER | Surgical Products Corp. | 1984-05-02 |
| K822448 | SCISSORS, VARIOUS | J. Sklar Mfg. Co., Inc. | 1982-09-14 |
| K821632 | SURGICAL SCISSORS, SET OF 3 | Fred Sammons, Inc. | 1982-06-24 |
| K821351 | CONPHAR DISSECTING SCISSORS | Conphar, Inc. | 1982-05-27 |
| K821350 | CONPHAR WIRE CUTTING SCISSORS | Conphar, Inc. | 1982-05-27 |
| K821352 | CONPHAR IRIS SCISSORS | Conphar, Inc. | 1982-05-27 |
| K821355 | CONPHAR LITTAUER SCISSORS | Conphar, Inc. | 1982-05-27 |
| K821361 | CONPHAR TONSIL SCISSORS | Conphar, Inc. | 1982-05-27 |
| K821112 | CONPHAR SCISSORS 4&1/2 SHARP BLUNT | Conphar, Inc. | 1982-05-07 |
| K821113 | OPERATING SCISSORS 5&1/2 CURVED SHARP | Conphar, Inc. | 1982-05-07 |
| K821114 | OPERATING SCISSORS CURVED 6 & 1/2 SHARP | Conphar, Inc. | 1982-05-07 |
| K821115 | SCISSORS CURVED 4 & 1/2 SHARP | Conphar, Inc. | 1982-05-07 |
Legacy Summary#
summary
FDA Review#
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