510(k) K971480
K971480 is an FDA 510(k) premarket notification submitted by Allied Biomedical Corp. for the device "DURALASTIC I AND DURALASTIC II". The FDA issued a decision of Substantially Equivalent on May 28, 1997. The device falls under product code MIB (Elastomer, Silicone Block), a Class II device regulated under 21 CFR 874.3620. Allied Biomedical Corp. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 1997
- Date Received
- April 23, 1997
- 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