510(k) K945552
K945552 is an FDA 510(k) premarket notification submitted by Applied Biomaterial Technologies for the device "DURALASTIC SHEETING". The FDA issued a decision of Substantially Equivalent on January 31, 1995. The device falls under product code MIB (Elastomer, Silicone Block), a Class II device regulated under 21 CFR 874.3620. Applied Biomaterial Technologies has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 1995
- Date Received
- November 10, 1994
- 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