The following data is part of a premarket notification filed by The Hygenic Corp. with the FDA for Endo-ice-pulp Tester-thermal.
| Device ID | K930764 |
| 510k Number | K930764 |
| Device Name: | ENDO-ICE-PULP TESTER-THERMAL |
| Classification | Tester, Pulp |
| Applicant | THE HYGENIC CORP. 1245 HOME AVE. Akron, OH 44310 -2575 |
| Contact | Meyer |
| Correspondent | Meyer THE HYGENIC CORP. 1245 HOME AVE. Akron, OH 44310 -2575 |
| Product Code | EAT |
| CFR Regulation Number | 872.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-12 |
| Decision Date | 1993-05-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854212006561 | K930764 | 000 |
| D82795475870 | K930764 | 000 |
| D77810650321 | K930764 | 000 |
| D771412050 | K930764 | 000 |
| H65811250561 | K930764 | 000 |