The following data is part of a premarket notification filed by Dalton Technology, Inc. with the FDA for Dalton Technology Flexible Screwdriver.
Device ID | K901166 |
510k Number | K901166 |
Device Name: | DALTON TECHNOLOGY FLEXIBLE SCREWDRIVER |
Classification | Screwdriver |
Applicant | DALTON TECHNOLOGY, INC. 6062 SAN FERNANDO RD. Glendale, CA 91202 |
Contact | James Lafferty |
Correspondent | James Lafferty DALTON TECHNOLOGY, INC. 6062 SAN FERNANDO RD. Glendale, CA 91202 |
Product Code | HXX |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-13 |
Decision Date | 1990-06-13 |