The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Icu Stopcok With Extension Tubing.
| Device ID | K953573 |
| 510k Number | K953573 |
| Device Name: | ICU STOPCOK WITH EXTENSION TUBING |
| Classification | Stopcock, I.v. Set |
| Applicant | ICU MEDICAL, INC. 951 CALLE AMANECER San Clemente, CA 92673 |
| Contact | Richard Waters |
| Correspondent | Richard Waters ICU MEDICAL, INC. 951 CALLE AMANECER San Clemente, CA 92673 |
| Product Code | FMG |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-31 |
| Decision Date | 1995-10-07 |