The following data is part of a premarket notification filed by J-tech Medical, Inc. with the FDA for Jtech Adjuster Reflex Gun.
| Device ID | K974376 |
| 510k Number | K974376 |
| Device Name: | JTECH ADJUSTER REFLEX GUN |
| Classification | Manipulator, Plunger-like Joint |
| Applicant | J-TECH MEDICAL, INC. PO BOX 4341 Crofton, MD 21114 |
| Contact | E.j Smith |
| Correspondent | E.j Smith J-TECH MEDICAL, INC. PO BOX 4341 Crofton, MD 21114 |
| Product Code | LXM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-20 |
| Decision Date | 1998-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G041CT0120 | K974376 | 000 |
| G041CT0060 | K974376 | 000 |
| G041CT0010 | K974376 | 000 |