The following data is part of a premarket notification filed by Moyco Union Broach, Div., Moyco Technologies, Inc. with the FDA for Integrator.
| Device ID | K950646 |
| 510k Number | K950646 |
| Device Name: | INTEGRATOR |
| Classification | Manipulator, Plunger-like Joint |
| Applicant | MOYCO UNION BROACH, DIV., MOYCO TECHNOLOGIES, INC. 589 DAVIES DR. York, PA 17402 |
| Contact | Chris M Lehr |
| Correspondent | Chris M Lehr MOYCO UNION BROACH, DIV., MOYCO TECHNOLOGIES, INC. 589 DAVIES DR. York, PA 17402 |
| 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 | 1995-02-13 |
| Decision Date | 1996-04-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H834015996131 | K950646 | 000 |
| H834015996121 | K950646 | 000 |
| H834015996030 | K950646 | 000 |
| H834015996000 | K950646 | 000 |