The following data is part of a premarket notification filed by Spembly Medical Ltd. with the FDA for Neurostat, Lloyd.
Device ID | K781302 |
510k Number | K781302 |
Device Name: | NEUROSTAT, LLOYD |
Classification | Device, Surgical, Cryogenic |
Applicant | SPEMBLY MEDICAL LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | GXH |
CFR Regulation Number | 882.4250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-07-28 |
Decision Date | 1978-08-15 |