The following data is part of a premarket notification filed by Echocath, Inc. with the FDA for Echomark Intrauterine Guiding Catheter.
| Device ID | K932436 |
| 510k Number | K932436 |
| Device Name: | ECHOMARK INTRAUTERINE GUIDING CATHETER |
| Classification | Catheters, Salpingography |
| Applicant | ECHOCATH, INC. P.O. BOX 7224 Princeton, NJ 08543 -7224 |
| Contact | Frank Debernardis |
| Correspondent | Frank Debernardis ECHOCATH, INC. P.O. BOX 7224 Princeton, NJ 08543 -7224 |
| Product Code | MOV |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-19 |
| Decision Date | 1995-11-16 |