The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Dgh A-san Probe Holder.
Device ID | K900162 |
510k Number | K900162 |
Device Name: | DGH A-SAN PROBE HOLDER |
Classification | Cap, Cervical |
Applicant | JEDMED INSTRUMENT CO. 1430 HANLEY INDUSTRIAL CT. St. Louis, MO 63144 |
Contact | Craig Rapp |
Correspondent | Craig Rapp JEDMED INSTRUMENT CO. 1430 HANLEY INDUSTRIAL CT. St. Louis, MO 63144 |
Product Code | HDR |
CFR Regulation Number | 884.5250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-12 |
Decision Date | 1990-02-16 |