510(k) K880997
K880997 is an FDA 510(k) premarket notification submitted by T. Korossurgical Instruments Corp. for the device "SPRING RETRACTOR". The FDA issued a decision of Substantially Equivalent on March 21, 1988. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. T. Korossurgical Instruments Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 1988
- Date Received
- March 8, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retractor
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type