The following data is part of a premarket notification filed by Medi-globe Corporation with the FDA for Polycatch Retrieval Device.
Device ID | K142258 |
510k Number | K142258 |
Device Name: | PolyCatch Retrieval Device |
Classification | Snare, Flexible |
Applicant | Medi-Globe Corporation 110 West Orion Street Tempe, AZ 85283 |
Contact | Scott Karler |
Correspondent | Scott Karler Medi-Globe Corporation 110 West Orion Street Tempe, AZ 85283 |
Product Code | FDI |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-14 |
Decision Date | 2014-09-30 |
Summary: | summary |