510(k) K760393
K760393 is an FDA 510(k) premarket notification submitted by Bemis Health Care for the device "BED PAN, STACKABLE (AUTOCLAVABLE)". The FDA issued a decision of Substantially Equivalent on August 23, 1976. The device falls under product code FOB (Bedpan), a Class I device regulated under 21 CFR 880.6730. Bemis Health Care has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 1976
- Date Received
- August 6, 1976
- 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