The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Introl Bladder Neck Support Prosthesis With Removal Tool.
| Device ID | K965040 |
| 510k Number | K965040 |
| Device Name: | INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL |
| Classification | Pessary, Vaginal |
| Applicant | JOHNSON & JOHNSON MEDICAL, INC. 2500 ARBROOK BLVD. P.O. BOX 90130 Arlington, TX 76004 -0130 |
| Contact | Ralph H Larsen |
| Correspondent | Ralph H Larsen JOHNSON & JOHNSON MEDICAL, INC. 2500 ARBROOK BLVD. P.O. BOX 90130 Arlington, TX 76004 -0130 |
| Product Code | HHW |
| CFR Regulation Number | 884.3575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-17 |
| Decision Date | 1997-03-10 |
| Summary: | summary |