The following data is part of a premarket notification filed by Aspen Labs with the FDA for Hand-trol S.
Device ID | K931215 |
510k Number | K931215 |
Device Name: | HAND-TROL S |
Classification | Electrosurgical Device |
Applicant | ASPEN LABS 14603 E. FREMONT AVE. Englewood, CO 80112 |
Contact | Jane Johnson |
Correspondent | Jane Johnson ASPEN LABS 14603 E. FREMONT AVE. Englewood, CO 80112 |
Product Code | DWG |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-10 |
Decision Date | 1994-03-28 |