The following data is part of a premarket notification filed by Circon Acmi with the FDA for Morris Anti-splatter Device For Endoscopes.
| Device ID | K884097 |
| 510k Number | K884097 |
| Device Name: | MORRIS ANTI-SPLATTER DEVICE FOR ENDOSCOPES |
| Classification | Endoscope Channel Accessory |
| Applicant | CIRCON ACMI 300 STILLWATER AVE. P.O. BOX 1971 Stamford, CT 06904 -1971 |
| Contact | Taylor, Pe |
| Correspondent | Taylor, Pe CIRCON ACMI 300 STILLWATER AVE. P.O. BOX 1971 Stamford, CT 06904 -1971 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-28 |
| Decision Date | 1989-04-17 |