The following data is part of a premarket notification filed by Primrose Medical, Inc. with the FDA for Colonic Balloon Dialators.
| Device ID | K884713 |
| 510k Number | K884713 |
| Device Name: | COLONIC BALLOON DIALATORS |
| Classification | Dilator, Rectal |
| Applicant | PRIMROSE MEDICAL, INC. 20 CABOT RD. Woburn, MA 01801 |
| Contact | Fletcher Longley |
| Correspondent | Fletcher Longley PRIMROSE MEDICAL, INC. 20 CABOT RD. Woburn, MA 01801 |
| Product Code | FFP |
| CFR Regulation Number | 876.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-08 |
| Decision Date | 1989-09-29 |