The following data is part of a premarket notification filed by Intl. Medical, Inc. with the FDA for American Catheter E.r.c.p. Cannula.
| Device ID | K940370 |
| 510k Number | K940370 |
| Device Name: | AMERICAN CATHETER E.R.C.P. CANNULA |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | INTL. MEDICAL, INC. 10061 AMBERWOOD RD. Fort Myers, FL 33913 |
| Contact | Peter H Wettermann |
| Correspondent | Peter H Wettermann INTL. MEDICAL, INC. 10061 AMBERWOOD RD. Fort Myers, FL 33913 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-26 |
| Decision Date | 1994-08-17 |