The following data is part of a premarket notification filed by A Plus International, Inc with the FDA for Operating Room Towels -sterile & Non-sterile.
Device ID | K881396 |
510k Number | K881396 |
Device Name: | OPERATING ROOM TOWELS -STERILE & NON-STERILE |
Classification | Drape, Surgical |
Applicant | A PLUS INTERNATIONAL, INC 275 S. 3RD AVE. #2 La Puente, CA 91746 |
Contact | David S Lee |
Correspondent | David S Lee A PLUS INTERNATIONAL, INC 275 S. 3RD AVE. #2 La Puente, CA 91746 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-04 |
Decision Date | 1988-04-29 |