The following data is part of a premarket notification filed by Sechrist Industries, Inc. with the FDA for Hyperbaric Intravenous Infusion Extension Set.
| Device ID | K884156 |
| 510k Number | K884156 |
| Device Name: | HYPERBARIC INTRAVENOUS INFUSION EXTENSION SET |
| Classification | Tubing, Fluid Delivery |
| Applicant | SECHRIST INDUSTRIES, INC. 2820 GRETTA LN. Anaheim, CA 92806 |
| Contact | Sandra L Davis |
| Correspondent | Sandra L Davis SECHRIST INDUSTRIES, INC. 2820 GRETTA LN. Anaheim, CA 92806 |
| Product Code | FPK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-04 |
| Decision Date | 1988-11-14 |