The following data is part of a premarket notification filed by Medical Technology Development Corp. with the FDA for Devmed Double-balloon Urological Catheter.
| Device ID | K941488 |
| 510k Number | K941488 |
| Device Name: | DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | MEDICAL TECHNOLOGY DEVELOPMENT CORP. P.O. BOX 1029 Santa Ynez, CA 93460 |
| Contact | Pamela G Goforth |
| Correspondent | Pamela G Goforth MEDICAL TECHNOLOGY DEVELOPMENT CORP. P.O. BOX 1029 Santa Ynez, CA 93460 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-28 |
| Decision Date | 1994-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10852732004033 | K941488 | 000 |
| 10852732004026 | K941488 | 000 |
| 10852732004002 | K941488 | 000 |