INSULIN PROTECTOR
FDA 510(k) clearance K073555 · decided 2008-07-11
Clearance details
- K-number
- K073555
- Device name
- INSULIN PROTECTOR
- Applicant
- Medicool, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-12-18
- Decision date
- 2008-07-11
- Days to decision
- 206 days
- Clearance type
- Traditional
- Product code
- IQG
- Device class
- 1
- Regulation number
- 890.5050
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Torrance, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| INSUCOZI INSULIN VIAL COVER (K072174) | 41 Industries, LLC | 2008-01-25 |
| ISECURE SYRINGE CARTRIDGE HOLDER (K063180) | Hospira, Inc. | 2006-12-11 |
Recalls involving this device
No recalls on record reference this clearance.