510(k) K891058
K891058 is an FDA 510(k) premarket notification submitted by Dispomed, Inc. for the device "DENTAL GOWN". The FDA issued a decision of Substantially Equivalent on April 12, 1989. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Dispomed, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 1989
- Date Received
- February 27, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gown, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type