510(k) K910468
K910468 is an FDA 510(k) premarket notification submitted by E.M. Adams for the device "STERILE DISPOSABLE DRAPE(S)". The FDA issued a decision of Substantially Equivalent on March 21, 1991. The device falls under product code FZI (Apparatus, Air Handling, Enclosure), a Class II device regulated under 21 CFR 878.5070. E.M. Adams has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 1991
- Date Received
- February 4, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Air Handling, Enclosure
- Device Class
- Class II
- Regulation Number
- 878.5070
- Review Panel
- SU
- Submission Type