The following data is part of a premarket notification filed by Medcare Custom Packaging, Inc. with the FDA for Sterile Physiological Saline/sterile Water.
| Device ID | K943661 |
| 510k Number | K943661 |
| Device Name: | STERILE PHYSIOLOGICAL SALINE/STERILE WATER |
| Classification | Catheter And Tip, Suction |
| Applicant | MEDCARE CUSTOM PACKAGING, INC. WINCHESTER ST. West Swanzey, NH 03469 -0069 |
| Contact | William A Hays |
| Correspondent | William A Hays MEDCARE CUSTOM PACKAGING, INC. WINCHESTER ST. West Swanzey, NH 03469 -0069 |
| Product Code | JOL |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-28 |
| Decision Date | 1995-04-10 |