510(k) K843477
K843477 is an FDA 510(k) premarket notification submitted by Zimmar Consulting , Ltd. for the device "PHARMA-PLAST RECTAL TIP". The FDA issued a decision of Substantially Equivalent on December 5, 1984. The device falls under product code FCF (Instrument, Biopsy, Mechanical, Gastrointestinal), a Class II device regulated under 21 CFR 876.1075. Zimmar Consulting , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 1984
- Date Received
- September 6, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Biopsy, Mechanical, Gastrointestinal
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- GU
- Submission Type