510(k) K971204
K971204 is an FDA 510(k) premarket notification submitted by Lsvp Intl., Inc. for the device "LSVP INTERNATIONAL HOT BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on May 27, 1997. The device falls under product code KGE (Forceps, Biopsy, Electric), a Class II device regulated under 21 CFR 876.4300. Lsvp Intl., Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 27, 1997
- Date Received
- April 1, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, Biopsy, Electric
- Device Class
- Class II
- Regulation Number
- 876.4300
- Review Panel
- GU
- Submission Type