The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Anesthesia Kit, Epidural, Single Shot.
Device ID | K770356 |
510k Number | K770356 |
Device Name: | ANESTHESIA KIT, EPIDURAL, SINGLE SHOT |
Classification | Anesthesia Conduction Kit |
Applicant | ARROW INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-02-22 |
Decision Date | 1977-03-01 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
40801902126083 | K770356 | 000 |
10801902067224 | K770356 | 000 |
20801902202042 | K770356 | 000 |
24026704736755 | K770356 | 000 |