The following data is part of a premarket notification filed by Inspired Ideas, Incorporated with the FDA for Foam Ring Port Protector.
Device ID | K062261 |
510k Number | K062261 |
Device Name: | FOAM RING PORT PROTECTOR |
Classification | Port, Protector/cushion |
Applicant | INSPIRED IDEAS, INCORPORATED 11460 N. MERIDIAN STREET SUITE 150 Carmel, IN 46032 |
Contact | Allison Scott |
Correspondent | Allison Scott INSPIRED IDEAS, INCORPORATED 11460 N. MERIDIAN STREET SUITE 150 Carmel, IN 46032 |
Product Code | OBK |
CFR Regulation Number | 880.5965 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-08-04 |
Decision Date | 2007-04-09 |
Summary: | summary |