510(k) K052505
K052505 is an FDA 510(k) premarket notification submitted by Implantech Associates, Inc. for the device "CALF IMPLANT, MODEL EC17-X". The FDA issued a decision of Substantially Equivalent on November 4, 2005. The device falls under product code MIB (Elastomer, Silicone Block), a Class II device regulated under 21 CFR 874.3620. Implantech Associates, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 4, 2005
- Date Received
- September 13, 2005
- 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