The following data is part of a premarket notification filed by Medical Device Technologies, Inc. with the FDA for Pbn Drainage Catheter Guidewires.
| Device ID | K991097 |
| 510k Number | K991097 |
| Device Name: | PBN DRAINAGE CATHETER GUIDEWIRES |
| Classification | Accessories, Catheter, G-u |
| Applicant | MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW 47TH AVENUE Gainesville, FL 32608 |
| Contact | Karl Swartz |
| Correspondent | Karl Swartz MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW 47TH AVENUE Gainesville, FL 32608 |
| Product Code | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-01 |
| Decision Date | 1999-04-23 |
| Summary: | summary |