The following data is part of a premarket notification filed by Taut, Inc. with the FDA for Pre Vue.
Device ID | K830573 |
510k Number | K830573 |
Device Name: | PRE VUE |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | TAUT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-02-23 |
Decision Date | 1983-03-29 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20613994952220 | K830573 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PRE VUE 74504853 not registered Dead/Abandoned |
Decked Out, Inc. 1994-03-25 |