510(k) K042380
K042380 is an FDA 510(k) premarket notification submitted by National Medical Devices, Inc. for the device "SILICONE BLOCK". The FDA issued a decision of Substantially Equivalent on October 25, 2004. The device falls under product code MIB (Elastomer, Silicone Block), a Class II device regulated under 21 CFR 874.3620.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 2004
- Date Received
- September 1, 2004
- 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