The following data is part of a premarket notification filed by Rantran, Inc. with the FDA for Saline For Irrigation.
Device ID | K932138 |
510k Number | K932138 |
Device Name: | SALINE FOR IRRIGATION |
Classification | Catheter And Tip, Suction |
Applicant | RANTRAN, INC. 2624 BEAVER GLEN DR. Ashland, VA 23005 |
Contact | Ed Ransom |
Correspondent | Ed Ransom RANTRAN, INC. 2624 BEAVER GLEN DR. Ashland, VA 23005 |
Product Code | JOL |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-21 |
Decision Date | 1994-11-04 |