510(k) K073555
K073555 is an FDA 510(k) premarket notification submitted by Medicool, Inc. for the device "INSULIN PROTECTOR". The FDA issued a decision of Substantially Equivalent on July 11, 2008. The device falls under product code IQG (Adaptor, Holder, Syringe), a Class I device regulated under 21 CFR 890.5050. Medicool, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 2008
- Date Received
- December 18, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adaptor, Holder, Syringe
- Device Class
- Class I
- Regulation Number
- 890.5050
- Review Panel
- HO
- Submission Type