The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Ackrad Mpr Drainage Catheter Set.
| Device ID | K901574 |
| 510k Number | K901574 |
| Device Name: | ACKRAD MPR DRAINAGE CATHETER SET |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Contact | Bernard Ackerman,phd |
| Correspondent | Bernard Ackerman,phd ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-03 |
| Decision Date | 1990-06-29 |