510(k) K791346
K791346 is an FDA 510(k) premarket notification submitted by General Clinical Plastics Corp. for the device "DISPOSABLE BEDPAN". The FDA issued a decision of Substantially Equivalent on August 3, 1979. The device falls under product code FOB (Bedpan), a Class I device regulated under 21 CFR 880.6730. General Clinical Plastics Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 3, 1979
- Date Received
- July 12, 1979
- 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