The following data is part of a premarket notification filed by Medical Laser, Inc. with the FDA for Modified Series 2100 Endoscopes.
Device ID | K912089 |
510k Number | K912089 |
Device Name: | MODIFIED SERIES 2100 ENDOSCOPES |
Classification | Mini Endoscope, Gastroenterology-urology |
Applicant | MEDICAL LASER, INC. 2605 FERNBROOK LN. Minneapolis, MN 55447 |
Contact | Gregory J Mathison |
Correspondent | Gregory J Mathison MEDICAL LASER, INC. 2605 FERNBROOK LN. Minneapolis, MN 55447 |
Product Code | ODF |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-05-13 |
Decision Date | 1991-08-12 |