The following data is part of a premarket notification filed by The Hygenic Corp. with the FDA for Endo-ice.
| Device ID | K881826 |
| 510k Number | K881826 |
| Device Name: | ENDO-ICE |
| Classification | Tester, Pulp |
| Applicant | THE HYGENIC CORP. 1245 HOME AVE. Akron, OH 44310 -2575 |
| Contact | T. N Meyer |
| Correspondent | T. N Meyer THE HYGENIC CORP. 1245 HOME AVE. Akron, OH 44310 -2575 |
| Product Code | EAT |
| CFR Regulation Number | 872.1720 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-29 |
| Decision Date | 1988-08-23 |