510(k) K802377
K802377 is an FDA 510(k) premarket notification submitted by Moti Enterprises, Inc. for the device "MOTI PROTECTIVE X-RAY MASK". The FDA issued a decision of Substantially Equivalent on October 31, 1980. The device falls under product code KPY (Shield, Protective, Personnel), a Class I device regulated under 21 CFR 892.6500. Moti Enterprises, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1980
- Date Received
- September 30, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shield, Protective, Personnel
- Device Class
- Class I
- Regulation Number
- 892.6500
- Review Panel
- RA
- Submission Type