510(k) K900894
- Device
- MEDILASE SERIES 2100 ENDOSCOPE
- Applicant
- Medical Laser, Inc.
- 510(k) number
- K900894
- Product code
- GCQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-06-22
- Date received
- 1990-02-27
- Regulation
- 876.1500
- Classification name
- Endoscope, Flexible
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- SHARON KARR
- Address
- 2605 Fernbrook Ln. Minneapolis MN US 55447 55447
FDA Registration Numbers#
- 2032521
- 3013445147
- 3009756153
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GCQ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K920979 | CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340) | Codman & Shurtleff, Inc. | 1993-03-23 |
| K871978 | CODMAN FLEXIBLE ENDOSCOPE | Codman & Shurtleff, Inc. | 1987-08-25 |
| K864960 | TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL. | Cooper Lasersonics, Inc. | 1987-02-10 |
| K860771 | VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE | Van-Tec, Inc. | 1986-04-23 |