510(k) K162624
K162624 is an FDA 510(k) premarket notification submitted by International Medical Devices, Inc. for the device "Pre-Formed Penile Silicone Block". The FDA issued a decision of Substantially Equivalent on February 1, 2017. The device falls under product code MIB (Elastomer, Silicone Block), a Class II device regulated under 21 CFR 874.3620. International Medical Devices, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 2017
- Date Received
- September 20, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Elastomer, Silicone Block
- Device Class
- Class II
- Regulation Number
- 874.3620
- Review Panel
- SU
- Submission Type