510(k) K852728
K852728 is an FDA 510(k) premarket notification submitted by The Huxley Instrument Corp. for the device "KELLY HEMOSTATIC FORCEPS, STRAIGHT 5-1/2+SS". The FDA issued a decision of Substantially Equivalent on July 15, 1985. The device falls under product code HTD (Forceps), a Class I device regulated under 21 CFR 878.4800. The Huxley Instrument Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 15, 1985
- Date Received
- June 26, 1985
- 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