510(k) K780370
K780370 is an FDA 510(k) premarket notification submitted by Medical Specialty Products, Inc. for the device "STAND UP TOILET". The FDA issued a decision of Substantially Equivalent on April 10, 1978. The device falls under product code FOB (Bedpan), a Class I device regulated under 21 CFR 880.6730. Medical Specialty Products, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 1978
- Date Received
- March 7, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bedpan
- Device Class
- Class I
- Regulation Number
- 880.6730
- Review Panel
- HO
- Submission Type