The following data is part of a premarket notification filed by Ulster Scientific, Inc. with the FDA for Neurotips(tm).
Device ID | K871571 |
510k Number | K871571 |
Device Name: | NEUROTIPS(TM) |
Classification | Esthesiometer |
Applicant | ULSTER SCIENTIFIC, INC. P.O. BOX 902 Highland, NY 12528 |
Contact | Robert K Mcewen |
Correspondent | Robert K Mcewen ULSTER SCIENTIFIC, INC. P.O. BOX 902 Highland, NY 12528 |
Product Code | GXB |
CFR Regulation Number | 882.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-22 |
Decision Date | 1987-06-18 |