510(k) K913882
K913882 is an FDA 510(k) premarket notification submitted by Byron Medical for the device "ZARA SILICONE BLOCK". The FDA issued a decision of Substantially Equivalent on April 21, 1992. The device falls under product code MIB (Elastomer, Silicone Block), a Class II device regulated under 21 CFR 874.3620. Byron Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1992
- Date Received
- August 29, 1991
- 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