510(k) K133425
- Device
- SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT
- Applicant
- ENGINEERED MEDICAL SOLUTIONS CO. LLC.
- 510(k) number
- K133425
- Product code
- FTD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-12-05
- Date received
- 2013-11-08
- Regulation
- 878.4580
- Classification name
- Lamp, Surgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RYAN SAVAGE
- Address
- 85 Industrial Dr. Bldg. B Phillipsburg NJ US 08865 08865
FDA Registration Numbers#
- 3004137296
- 3011580044
- 3011706110
- 3033433849
- 3016590299
- 3001104093
- 3004361444
- 3015729
- 9611500
- 3004187094
- 3019729879
- 2650143
- 1066635
- 9710055
- 3011910987
- 1000122786
- 3009631939
- 2528981
- 3008716327
- 3016904853
- 1043214
- 8044093
- 3015978022
- 3017815086
- 3006467297
- 1287329
- 3013115071
- 3003707320
- 3010273872
- 3013524663
- 3005977121
- 3015444963
- 3000286616
- 2648666
- 3010373494
- 8010177
- 3007836437
- 3005726841
- 3027847726
- 9614609
- 3009715914
- 3010421104
- 3017265430
- 3003882387
- 1037039
- 2030624
- 1047843
- 8031020
- 3008610343
- 3008538162
- 3011137372
- 9681407
- 3031563141
- 3009905888
- 3012092534
- 1066427
- 3017970309
- 3007143268
- 3010041511
- 3008808049
Source Documents#
Other 510(k) Records For Product Code FTD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K130513 | VOLISTA 400; VOLISTA 600 | Maquet S.A.S. | 2013-05-08 |
| K123776 | POLARIS 100/200 | Drager Medical GmbH | 2013-03-08 |
| K111020 | ATRICURE DISSECTOR | AtriCure, Inc. | 2011-06-09 |
| K100234 | HM-LAMP II | Hillusa, Inc. | 2010-07-08 |
| K100884 | STRYKER KNIFELIGHT | Howmedica Osteonics Corp. | 2010-06-25 |
| K071180 | SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 | Engineered Medical Solutions Co., LLC | 2007-06-20 |
| K053364 | HALUX IRIS EXAMINATION AND SURGICAL LAMP | Waldmann Lighting | 2006-02-23 |
| K041681 | ATRICURE DISSECTOR | AtriCure, Inc. | 2004-07-01 |
| K013242 | AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM | STERIS Corporation | 2001-12-13 |
| K010724 | SOLA 700,SOLA 500, SOLA 300 | Drager Medizintechnik GmbH | 2001-06-07 |
| K003423 | ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 | St. Francis Medical Equipment Co., Ltd. | 2001-02-22 |
| K981717 | STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR | Stryker Instruments | 1998-06-30 |
| K961122 | STRYKER KNIFELIGHT | Stryker Instruments | 1996-08-22 |
| K954263 | XE-LITE | Ophthalmic Technologies, Inc. | 1995-10-18 |
| K942553 | GENESIS | Burton Medical Products Corp. | 1994-06-23 |
Legacy Summary#
summary
FDA Review#
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