510(k) K982058
K982058 is an FDA 510(k) premarket notification submitted by Encompass Group, LLC for the device "ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN". The FDA issued a decision of Substantially Equivalent on Jan 14, 1999. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Encompass Group, LLC has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 14, 1999
- Date Received
- Jun 11, 1998
- 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
- 510(k)