The following data is part of a premarket notification filed by Mediplus Ltd. with the FDA for Suprapubic Catheter And Introducer Set.
Device ID | K132890 |
510k Number | K132890 |
Device Name: | SUPRAPUBIC CATHETER AND INTRODUCER SET |
Classification | Catheter, Suprapubic (and Accessories) |
Applicant | MEDIPLUS LTD. UNIT 7, THE GATEWAY CENTRE CORONATION RD, CRESSEX BUS. PK. High Wycombe, Bucks, GB Hp12 35u |
Contact | Paul Dryden |
Correspondent | Paul Dryden MEDIPLUS LTD. UNIT 7, THE GATEWAY CENTRE CORONATION RD, CRESSEX BUS. PK. High Wycombe, Bucks, GB Hp12 35u |
Product Code | KOB |
CFR Regulation Number | 876.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-09-16 |
Decision Date | 2014-01-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
15055140702262 | K132890 | 000 |
15055140700107 | K132890 | 000 |
15055140700114 | K132890 | 000 |
15055140701197 | K132890 | 000 |
15055140701203 | K132890 | 000 |
15055140701210 | K132890 | 000 |
15055140701227 | K132890 | 000 |
15055140701333 | K132890 | 000 |
15055140701340 | K132890 | 000 |
15055140701609 | K132890 | 000 |
15055140702231 | K132890 | 000 |
15055140700091 | K132890 | 000 |