The following data is part of a premarket notification filed by Electrical Systems Div. with the FDA for Esi Model Ms-103.
Device ID | K885120 |
510k Number | K885120 |
Device Name: | ESI MODEL MS-103 |
Classification | Retractor, Self-retaining, For Neurosurgery |
Applicant | ELECTRICAL SYSTEMS DIV. 8918 TESORO DR. SUITE 120 San Antonio, TX 78217 |
Contact | Patrick T Thayer |
Correspondent | Patrick T Thayer ELECTRICAL SYSTEMS DIV. 8918 TESORO DR. SUITE 120 San Antonio, TX 78217 |
Product Code | GZT |
CFR Regulation Number | 882.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-12-12 |
Decision Date | 1990-01-19 |