The following data is part of a premarket notification filed by Medica Corp. with the FDA for Capillary Adaptor Accessory.
| Device ID | K963992 |
| 510k Number | K963992 |
| Device Name: | CAPILLARY ADAPTOR ACCESSORY |
| Classification | Electrode, Ion-specific, Chloride |
| Applicant | MEDICA CORP. 14 DEANGELO DR. Bedford, MA 01730 |
| Contact | Photios Makris |
| Correspondent | Photios Makris MEDICA CORP. 14 DEANGELO DR. Bedford, MA 01730 |
| Product Code | CGZ |
| Subsequent Product Code | CEM |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JIH |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-04 |
| Decision Date | 1996-11-29 |