The following data is part of a premarket notification filed by Ideas For Medicine, Inc. with the FDA for Modified Info Inserts For Pruitt Irri.-occlu. Cath.
| Device ID | K872154 |
| 510k Number | K872154 |
| Device Name: | MODIFIED INFO INSERTS FOR PRUITT IRRI.-OCCLU. CATH |
| Classification | Occluder, Catheter Tip |
| Applicant | IDEAS FOR MEDICINE, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
| Contact | Mark R Waddell |
| Correspondent | Mark R Waddell IDEAS FOR MEDICINE, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
| Product Code | DQT |
| CFR Regulation Number | 870.1370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-01 |
| Decision Date | 1987-08-03 |