510(k) K896110
K896110 is an FDA 510(k) premarket notification submitted by Sterling Drug, Inc. for the device "BIOBRANE(R) II". The FDA issued a decision of Substantially Equivalent on November 28, 1989. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Sterling Drug, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 28, 1989
- Date Received
- October 23, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Dressing With Animal-Derived Material(S)
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type