510(k) K770636
K770636 is an FDA 510(k) premarket notification submitted by I E Industries for the device "TABLE, EXAM & MANUPULATION". The FDA issued a decision of Substantially Equivalent on April 15, 1977. The device falls under product code INT (Plinth), a Class I device regulated under 21 CFR 890.3520. I E Industries has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 15, 1977
- Date Received
- April 4, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plinth
- Device Class
- Class I
- Regulation Number
- 890.3520
- Review Panel
- PM
- Submission Type