The following data is part of a premarket notification filed by Pro-med Instruments Gmbh with the FDA for Doro Headrest System.
Device ID | K001808 |
510k Number | K001808 |
Device Name: | DORO HEADREST SYSTEM |
Classification | Holder, Head, Neurosurgical (skull Clamp) |
Applicant | PRO-MED INSTRUMENTS GMBH 9070 BLUFFVIEW TRACE Roswell, GA 30076 |
Contact | Anita Thibeault |
Correspondent | Anita Thibeault PRO-MED INSTRUMENTS GMBH 9070 BLUFFVIEW TRACE Roswell, GA 30076 |
Product Code | HBL |
CFR Regulation Number | 882.4460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-06-15 |
Decision Date | 2000-08-04 |