The following data is part of a premarket notification filed by Oldelft Corp. Of America with the FDA for Electrodelca.
Device ID | K892659 |
510k Number | K892659 |
Device Name: | ELECTRODELCA |
Classification | System, X-ray, Photofluorographic |
Applicant | OLDELFT CORP. OF AMERICA 2735 DORR AVE. Fairfax, VA 22031 |
Contact | Charles Pattie |
Correspondent | Charles Pattie OLDELFT CORP. OF AMERICA 2735 DORR AVE. Fairfax, VA 22031 |
Product Code | IZG |
CFR Regulation Number | 892.1730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-13 |
Decision Date | 1989-11-21 |