510(k) K823455
K823455 is an FDA 510(k) premarket notification submitted by Worldwide Surgical Gauze for the device "SURGICAL GAUZE". The FDA issued a decision of Substantially Equivalent on January 28, 1983. Worldwide Surgical Gauze has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 1983
- Date Received
- November 18, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No