510(k) K873555
K873555 is an FDA 510(k) premarket notification submitted by Gorsk, Inc. for the device "GORSK SPONGE CONTAINMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on October 23, 1987. The device falls under product code LWH (Counter, Sponge, Surgical), a Class I device regulated under 21 CFR 880.2740. Gorsk, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 1987
- Date Received
- August 28, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Counter, Sponge, Surgical
- Device Class
- Class I
- Regulation Number
- 880.2740
- Review Panel
- SU
- Submission Type