The following data is part of a premarket notification filed by Medcare Medical Group, Inc. with the FDA for Medcare Regional Anethesia Kit.
Device ID | K961075 |
510k Number | K961075 |
Device Name: | MEDCARE REGIONAL ANETHESIA KIT |
Classification | Anesthesia Conduction Kit |
Applicant | MEDCARE MEDICAL GROUP, INC. 234 OLD HOMESTEAD HWY. East Swanzey, NH 03446 |
Contact | Craig J Bell |
Correspondent | Craig J Bell MEDCARE MEDICAL GROUP, INC. 234 OLD HOMESTEAD HWY. East Swanzey, NH 03446 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-18 |
Decision Date | 1996-09-06 |
Summary: | summary |