The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Silicone Elastomer Infusion Catheter.
| Device ID | K813606 |
| 510k Number | K813606 |
| Device Name: | SILICONE ELASTOMER INFUSION CATHETER |
| Classification | Catheter, Infusion |
| Applicant | QUEST MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JCY |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-29 |
| Decision Date | 1982-01-18 |