510(k) K051985
- Device
- BIOVALVE MINI-JECT NEEDLEFREE INJECTOR
- Applicant
- BIOVALVE TECHNOLOGIES, INC.
- 510(k) number
- K051985
- Product code
- KZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-08-17
- Date received
- 2005-07-22
- Regulation
- 880.5430
- Classification name
- Injector, Fluid, Non-electrically Powered
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SCOTT HUIE
- Address
- 155 Flanders Rd. Westborough MA US 01581 01581
FDA Registration Numbers#
- 3002939152
- 3009339779
- 2225311
- 3005695724
- 3027739783
- 2027063
- 3012132406
- 3004977013
- 3008729892
- 3010421104
- 2029275
- 3008717566
Source Documents#
Other 510(k) Records For Product Code KZE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K121270 | BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM | Bioject Medical Technologies, Inc. | 2012-07-19 |
| K111517 | PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI | Pharmajet, Inc. | 2011-07-27 |
| K110456 | PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM | Pharmajet, Inc. | 2011-03-02 |
| K090959 | LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA | D'Antonio Consultants International, Inc. (Dci) | 2009-12-24 |
| K090003 | ZETAJET | Bioject, Inc. | 2009-04-02 |
| K081532 | PHARMAJET NEEDLE-FREE INJECTION SYSTEM | Pharmajet, Inc. | 2009-02-26 |
| K082138 | AIRGENT, MODEL AG7000010 | Perfaction, Inc. | 2009-01-23 |
| K060819 | COOL.CLICK 2 | Medical House Products Limited | 2006-06-16 |
| K050734 | COOL.CLICK | Bioject, Inc. | 2005-06-03 |
| K041239 | GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000 | Genesis Medical Technology, Inc. | 2004-11-08 |
| K041280 | HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500 | Felton International, Inc. | 2004-06-24 |
| K032976 | BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001 | Biovalve Technologies, Inc. | 2004-04-16 |
| K024018 | AVANT GUARDIAN 101 | Avant Medical Corporation | 2003-01-17 |
| K020786 | INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM | Rosch AG Medizintechnic | 2002-09-25 |
| K022502 | INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000 | Equidyne Systems, Inc. | 2002-09-05 |
Legacy Summary#
summary
FDA Review#
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