510(k) K800237
K800237 is an FDA 510(k) premarket notification submitted by Husa Folding Crutch Co., Inc. for the device "FOLDING CRUTCH". The FDA issued a decision of Substantially Equivalent on February 22, 1980. The device falls under product code IPR (Crutch), a Class I device regulated under 21 CFR 890.3150.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 1980
- Date Received
- February 5, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Crutch
- Device Class
- Class I
- Regulation Number
- 890.3150
- Review Panel
- PM
- Submission Type