510(k) K120204
K120204 is an FDA 510(k) premarket notification submitted by Sterilmed, Inc. for the device "REPROCESSED FEMORAL COMPRESSION DEVICE". The FDA issued a decision of Substantially Equivalent on April 3, 2012. The device falls under product code NMF (Clamp, Vascular, Reprocessed), a Class II device regulated under 21 CFR 870.4450. Sterilmed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 2012
- Date Received
- January 23, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Vascular, Reprocessed
- Device Class
- Class II
- Regulation Number
- 870.4450
- Review Panel
- CV
- Submission Type
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).