The following data is part of a premarket notification filed by Medron, Inc. with the FDA for Injection Cap.
Device ID | K940775 |
510k Number | K940775 |
Device Name: | INJECTION CAP |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | MEDRON, INC. 3614 WEST 2100 SOUTH Salt Lake City, UT 84120 |
Contact | Ron Wortley |
Correspondent | Ron Wortley MEDRON, INC. 3614 WEST 2100 SOUTH Salt Lake City, UT 84120 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-22 |
Decision Date | 1994-06-15 |