The following data is part of a premarket notification filed by Technical Products, Inc. with the FDA for Silicone Malecot Catheter With Pezzer/mushroom Tip.
| Device ID | K954116 |
| 510k Number | K954116 |
| Device Name: | SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP |
| Classification | Catheter, Malecot |
| Applicant | TECHNICAL PRODUCTS, INC. 2416 PARK CENTRAL BLVD. Decatur, GA 30035 |
| Contact | Norbert D Thompson |
| Correspondent | Norbert D Thompson TECHNICAL PRODUCTS, INC. 2416 PARK CENTRAL BLVD. Decatur, GA 30035 |
| Product Code | FEW |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-20 |
| Decision Date | 1995-11-06 |