510(k) K910914
K910914 is an FDA 510(k) premarket notification submitted by Cook Urological, Inc. for the device "SURGICAL TISSUE POUCH". The FDA issued a decision of Substantially Equivalent on March 28, 1991. The device falls under product code KGY (Bag, Intestine), a Class I device regulated under 21 CFR 878.4100. Cook Urological, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 1991
- Date Received
- March 5, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bag, Intestine
- Device Class
- Class I
- Regulation Number
- 878.4100
- Review Panel
- SU
- Submission Type