510(k) K901152
K901152 is an FDA 510(k) premarket notification submitted by Medical Accessories, Inc. for the device "REDYPLATE DISPOSABLE LEG PLATE". The FDA issued a decision of Substantially Equivalent on April 4, 1990. The device falls under product code HGP (Electrode, Circular (Spiral), Scalp And Applicator), a Class II device regulated under 21 CFR 884.2675. Medical Accessories, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 1990
- Date Received
- March 13, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Circular (Spiral), Scalp And Applicator
- Device Class
- Class II
- Regulation Number
- 884.2675
- Review Panel
- OB
- Submission Type