510(k) K873795
- Device
- M-LENS (THIRTY DEGREE ENDOSCOPE)
- Applicant
- Opto Vision, Inc.
- 510(k) number
- K873795
- Product code
- FEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-01-14
- Date received
- 1987-09-17
- Regulation
- 876.1500
- Classification name
- Instrument, Special Lens, For Endoscope
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- HELMUT KREBS
- Address
- 4849 N. Kenneth Ave. Chicago IL US 60630 60630
FDA Registration Numbers#
- 3004902874
- 3016851379
- 3012358417
- 1220246
- 3002579136
- 3011137372
- 3010202439
- 2020550
- 1219602
- 3033043422
- 8040278
- 3030926959
- 3015231789
- 3002907620
- 3010041511
- 3012470322
- 3001556604
- 3021393544
- 3006990600
- 1220477
- 3003755939
- 3006696607
- 3010400367
- 3014262693
- 3021336182
- 8043980
- 3009217531
- 3015974593
- 3012883081
- 3010331645
- 3008720584
- 1643264
- 3003604053
- 3016727307
- 3015972835
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FEI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K862872 | FLEXIBLE VISUALIZATION CATHETER | American Edwards Laboratories | 1986-10-24 |