510(k) K802868
K802868 is an FDA 510(k) premarket notification submitted by Surgical Systems, Inc. for the device "ACCU-COUNTER SURGICAL SPONGE COUNTING SY". The FDA issued a decision of Substantially Equivalent on December 19, 1980. Surgical Systems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 1980
- Date Received
- November 14, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No