510(k) K895235
K895235 is an FDA 510(k) premarket notification submitted by Protect Corp. of Indiana, Inc. for the device "VARIOUS DISPOSABLE SURGICAL GARMENTS". The FDA issued a decision of Substantially Equivalent on September 19, 1989. The device falls under product code FYE (Dress, Surgical), a Class I device regulated under 21 CFR 878.4040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 19, 1989
- Date Received
- August 7, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dress, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4040
- Review Panel
- SU
- Submission Type