The following data is part of a premarket notification filed by Hinatawada Seimitsu Mfg. Co., Ltd. with the FDA for Air Medica Iii.
Device ID | K920710 |
510k Number | K920710 |
Device Name: | AIR MEDICA III |
Classification | Unit, Operative Dental |
Applicant | HINATAWADA SEIMITSU MFG. CO., LTD. 1101 CAPITAL OF TEXAS HGWY, S. Austin, TX 78746 |
Contact | Wester, Jr |
Correspondent | Wester, Jr HINATAWADA SEIMITSU MFG. CO., LTD. 1101 CAPITAL OF TEXAS HGWY, S. Austin, TX 78746 |
Product Code | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-18 |
Decision Date | 1992-05-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AIR MEDICA III 74505905 1882015 Dead/Cancelled |
Daido Corporation 1994-03-28 |