510(k) K820505
K820505 is an FDA 510(k) premarket notification submitted by Mauch Laboratories, Inc. for the device "ANKLE/FOOT EXTERNAL". The FDA issued a decision of Substantially Equivalent on March 8, 1982. The device falls under product code ISH (Component, External, Limb, Ankle/Foot), a Class I device regulated under 21 CFR 890.3420.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 1982
- Date Received
- February 25, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Component, External, Limb, Ankle/Foot
- Device Class
- Class I
- Regulation Number
- 890.3420
- Review Panel
- PM
- Submission Type