510(k) K843475
K843475 is an FDA 510(k) premarket notification submitted by Zimmar Consulting , Ltd. for the device "PHARMA-PLAST SINGLE USE OVERSHOES". The FDA issued a decision of Substantially Equivalent on October 31, 1984. The device falls under product code FXP (Cover, Shoe, Operating-Room), a Class I device regulated under 21 CFR 878.4040. Zimmar Consulting , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1984
- Date Received
- September 6, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cover, Shoe, Operating-Room
- Device Class
- Class I
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type