The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for Reusable Hand-trol.
| Device ID | K800597 |
| 510k Number | K800597 |
| Device Name: | REUSABLE HAND-TROL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ASPEN LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-17 |
| Decision Date | 1980-04-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40653405008614 | K800597 | 000 |
| 40653405008607 | K800597 | 000 |
| 40653405008591 | K800597 | 000 |
| 40653405008584 | K800597 | 000 |
| 40653405008577 | K800597 | 000 |
| 00653405008616 | K800597 | 000 |
| 00653405008579 | K800597 | 000 |