The following data is part of a premarket notification filed by Hemotec, Inc. with the FDA for Calcium Chloride Solution 0.1m, In Hepes Buffer.
| Device ID | K880302 |
| 510k Number | K880302 |
| Device Name: | CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER |
| Classification | Plasma, Coagulation Control |
| Applicant | HEMOTEC, INC. 7103 SOUTH REVERE PKWY. Englewood, CO 80112 |
| Contact | Baugh, Phd |
| Correspondent | Baugh, Phd HEMOTEC, INC. 7103 SOUTH REVERE PKWY. Englewood, CO 80112 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-25 |
| Decision Date | 1988-02-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885074184937 | K880302 | 000 |