510(k) K923187
K923187 is an FDA 510(k) premarket notification submitted by Dynatech Medical Products for the device "IMPERVIOUS ISOLATION SHOE COVERS". The FDA issued a decision of Substantially Equivalent on January 29, 1993. The device falls under product code FXW (Shoes, Operating-Room), a Class I device regulated under 21 CFR 878.4040. Dynatech Medical Products has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 1993
- Date Received
- June 30, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shoes, Operating-Room
- Device Class
- Class I
- Regulation Number
- 878.4040
- Review Panel
- SU
- Submission Type