510(k) K913964
K913964 is an FDA 510(k) premarket notification submitted by Marlo Surgical Technology for the device "MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS". The FDA issued a decision of Substantially Equivalent on October 23, 1991. The device falls under product code HTD (Forceps), a Class I device regulated under 21 CFR 878.4800. Marlo Surgical Technology has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 1991
- Date Received
- September 5, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type