The following data is part of a premarket notification filed by Almore Intl., Inc. with the FDA for Straight 5 Hemostat.
Device ID | K831137 |
510k Number | K831137 |
Device Name: | STRAIGHT 5 HEMOSTAT |
Classification | Forceps |
Applicant | ALMORE INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HTD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-07 |
Decision Date | 1983-05-18 |