510(k) K801304
K801304 is an FDA 510(k) premarket notification submitted by Johannah Medical Services, Inc. for the device "CAMLOC SYRINGE BIOPSY KIT". The FDA issued a decision of Substantially Equivalent on June 17, 1980. The device falls under product code GEE (Brush, Biopsy, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Johannah Medical Services, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 1980
- Date Received
- June 8, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Brush, Biopsy, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type