510(k) K083702
- Device
- TRACH-ASSIST
- Applicant
- MERGENET MEDICAL
- 510(k) number
- K083702
- Product code
- BZA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-03-05
- Date received
- 2008-12-15
- Regulation
- 868.5810
- Classification name
- Connector, Airway (extension)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL DRYDEN
- Address
- 24301 Woodsage Dr. Bonita Springs FL US 34134 34134
FDA Registration Numbers#
- 3011353843
- 3014228009
- 3017844574
- 8021995
- 3017751928
- 3006606984
- 3011237770
- 8030229
- 1928237
- 3022120197
- 9710391
- 1832562
- 1526863
- 3016634999
- 9611500
- 2518436
- 3002807267
- 1820334
- 3005783425
- 3001313714
- 3004415095
- 3009512503
- 8010939
- 1319447
- 3007494890
- 3029706818
- 3008693658
- 3021244152
- 3009039068
- 3031369651
- 8022611
- 1000484830
- 3018762668
- 3020751316
- 3018094310
- 3014579161
- 3003431869
- 8044004
- 3015191173
- 3012316249
- 3014541700
- 8022265
- 3011137372
- 9617604
- 3009887154
- 2085602
- 3012262567
- 3000126629
- 3027579175
- 1824231
- 3008281139
- 3022949799
- 3016710298
- 2080783
- 2427500
- 3003862188
- 3023294726
- 8020864
- 3011780089
- 2936999
- 9680661
- 3004111573
- 9710641
- 3003528228
- 3016458361
- 3010272829
- 3017202422
- 3006897516
- 2020813
- 1018470
- 3009291251
- 2028807
- 9611252
- 3003898360
- 3013298431
- 3009771213
- 3009490946
- 2022648
- 3004365956
- 3013528571
Source Documents#
Other 510(k) Records For Product Code BZA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K954383 | SURELOC CIRCUIT CONNECTOR | Polamedco, Inc. | 1995-12-22 |
| K954197 | DISPOSABLE FLEX TUBE | Engstrom Medical | 1995-10-26 |
| K953786 | UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS | Unicor, Inc. | 1995-09-19 |
| K952824 | NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR | Intertex Medical, Inc. | 1995-07-20 |
| K951345 | DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING | Catheter Research, Inc. | 1995-04-14 |
| K944532 | PRIMA, INC. VENTILATOR HOSES | Prima, Inc. | 1994-12-02 |
| K944534 | PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS | Prima, Inc. | 1994-11-29 |
| K944535 | PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS | Prima, Inc. | 1994-11-29 |
| K942392 | AIRWAY CONNECTOR WITH FLEX TUBE | Mallinckrodt Medical | 1994-08-22 |
| K941026 | THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR | Thayer Medical Corp. | 1994-08-18 |
| K940793 | DOUBLE TRACH SWIVEL CONNECTOR | Seven Harvest Intl. Import & Export | 1994-07-01 |
| K940544 | DOUBLE TRACH SEIVEL CONNECTOR | Fvtnks | 1994-04-19 |
| K935821 | DOUBLE TRACH SWIVEL CONNECTOR | Nutec, Inc. | 1994-01-14 |
| K931800 | MAG CONNECTORS AND AIRWAY EXTENSIONS | Mag, Inc. | 1993-05-19 |
| K931216 | CONNECTORS AND AIRWAY EXTENSIONS | Teknor Medical Products, Inc. | 1993-04-23 |
Legacy Summary#
summary
FDA Review#
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