510(k) K911132
K911132 is an FDA 510(k) premarket notification submitted by Central Georgia Ancillary Health Systems for the device "MULTIPLE, SURGICAL DRAPE PACK". The FDA issued a decision of Substantially Equivalent on May 6, 1991. The device falls under product code FZI (Apparatus, Air Handling, Enclosure), a Class II device regulated under 21 CFR 878.5070. Central Georgia Ancillary Health Systems has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 1991
- Date Received
- March 14, 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