The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit Disposal Depot(tm).
Device ID | K914208 |
510k Number | K914208 |
Device Name: | MERIT DISPOSAL DEPOT(TM) |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | MERIT MEDICAL SYSTEMS, INC. 79 WEST 4500 SOUTH SUITE 9 Salt Lake City, UT 84107 |
Contact | Dennis Reigle |
Correspondent | Dennis Reigle MERIT MEDICAL SYSTEMS, INC. 79 WEST 4500 SOUTH SUITE 9 Salt Lake City, UT 84107 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-09-19 |
Decision Date | 1991-12-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20884450050105 | K914208 | 000 |
20884450028579 | K914208 | 000 |
10884450024451 | K914208 | 000 |
20884450022850 | K914208 | 000 |
20884450022089 | K914208 | 000 |
20884450019607 | K914208 | 000 |
20884450013421 | K914208 | 000 |
20884450008236 | K914208 | 000 |
20884450008229 | K914208 | 000 |