510(k) K891820
K891820 is an FDA 510(k) premarket notification submitted by Bioshield, Inc. for the device "DISPOSABLE MEDICAL GOWNS". The FDA issued a decision of Substantially Equivalent on July 24, 1989. The device falls under product code FYB (Gown, Patient), a Class II device regulated under 21 CFR 878.4040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 1989
- Date Received
- March 20, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gown, Patient
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type