The following data is part of a premarket notification filed by Coast Medical, Inc. with the FDA for Extension Set/i.v. Set.
| Device ID | K952243 |
| 510k Number | K952243 |
| Device Name: | EXTENSION SET/I.V. SET |
| Classification | Tubing, Fluid Delivery |
| Applicant | COAST MEDICAL, INC. 1060 NORTH BATAVIA UNIT H Orange, CA 92667 |
| Contact | Tim L Truitt |
| Correspondent | Tim L Truitt COAST MEDICAL, INC. 1060 NORTH BATAVIA UNIT H Orange, CA 92667 |
| Product Code | FPK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-12 |
| Decision Date | 1995-07-26 |