The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for Excalibur Plus Electrosurgical Unit.
Device ID | K953007 |
510k Number | K953007 |
Device Name: | EXCALIBUR PLUS ELECTROSURGICAL UNIT |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | ASPEN LABORATORIES, INC. 14603 E. FREMONT AVE. Englewood, CO 80112 |
Contact | Charles M Hart |
Correspondent | Charles M Hart ASPEN LABORATORIES, INC. 14603 E. FREMONT AVE. Englewood, CO 80112 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-28 |
Decision Date | 1995-08-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10653405010999 | K953007 | 000 |
10653405010975 | K953007 | 000 |