The following data is part of a premarket notification filed by Ulti-med Intl., Inc. with the FDA for Absorbent, Fiber, Operating Room Towels.
Device ID | K860936 |
510k Number | K860936 |
Device Name: | ABSORBENT, FIBER, OPERATING ROOM TOWELS |
Classification | Drape, Surgical |
Applicant | ULTI-MED INTL., INC. 710 E. REMINGTON RD. Schaumburg, IL 60173 |
Contact | Steve T Shen |
Correspondent | Steve T Shen ULTI-MED INTL., INC. 710 E. REMINGTON RD. Schaumburg, IL 60173 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-12 |
Decision Date | 1986-04-04 |