510(k) K161346
K161346 is an FDA 510(k) premarket notification submitted by NormaTec Industries, LP for the device "NormaTec PCD-T and PCD-B". The FDA issued a decision of Substantially Equivalent on Jun 15, 2016. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. NormaTec Industries, LP has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 15, 2016
- Date Received
- May 16, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Sleeve, Limb, Compressible
- Device Class
- Class II
- Regulation Number
- 870.5800
- Review Panel
- CV
- Submission Type