The following data is part of a premarket notification filed by Ispg, Inc. with the FDA for Anesthesia Conduction Needle.
Device ID | K962886 |
510k Number | K962886 |
Device Name: | ANESTHESIA CONDUCTION NEEDLE |
Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
Applicant | ISPG, INC. 517 LITCHFIELD RD. New Milford, CT 06776 |
Contact | Loretta F Luhman |
Correspondent | Loretta F Luhman ISPG, INC. 517 LITCHFIELD RD. New Milford, CT 06776 |
Product Code | BSP |
CFR Regulation Number | 868.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-24 |
Decision Date | 1996-10-09 |