510(k) K961057
K961057 is an FDA 510(k) premarket notification submitted by Rand Scientific Corp. for the device "DURALASTIC SHEETING II". The FDA issued a decision of Substantially Equivalent on May 16, 1996. The device falls under product code MIB (Elastomer, Silicone Block), a Class II device regulated under 21 CFR 874.3620. Rand Scientific Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 1996
- Date Received
- March 18, 1996
- 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