510(k) K940238
K940238 is an FDA 510(k) premarket notification submitted by Camp Intl., Inc. for the device "TUMBLE FORMS JUNIOR TRISTANDER". The FDA issued a decision of Substantially Equivalent on March 7, 1994. The device falls under product code INW (Table, Mechanical), a Class I device regulated under 21 CFR 890.3750. Camp Intl., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 7, 1994
- Date Received
- January 19, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Mechanical
- Device Class
- Class I
- Regulation Number
- 890.3750
- Review Panel
- PM
- Submission Type