510(k) K172987
K172987 is an FDA 510(k) premarket notification submitted by Gmax Industries, Inc. for the device "Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)". The FDA issued a decision of Substantially Equivalent on Jul 13, 2018. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 13, 2018
- Date Received
- Sep 27, 2017
- 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)