510(k) K822305
K822305 is an FDA 510(k) premarket notification submitted by Frontier Products for the device "ORTHO-LEVEL". The FDA issued a decision of Substantially Equivalent on August 20, 1982. The device falls under product code HTH (Protractor), a Class I device regulated under 21 CFR 888.4600. Frontier Products has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 1982
- Date Received
- July 27, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Protractor
- Device Class
- Class I
- Regulation Number
- 888.4600
- Review Panel
- OR
- Submission Type