The following data is part of a premarket notification filed by Ulti-med Intl., Inc. with the FDA for Laceration Tray.
Device ID | K873439 |
510k Number | K873439 |
Device Name: | LACERATION TRAY |
Classification | Tray, Surgical |
Applicant | ULTI-MED INTL., INC. 710 E. REMINGTON RD. Schaumburg, IL 60173 |
Contact | John Floren |
Correspondent | John Floren ULTI-MED INTL., INC. 710 E. REMINGTON RD. Schaumburg, IL 60173 |
Product Code | LRP |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-27 |
Decision Date | 1987-09-11 |