510(k) K121998
K121998 is an FDA 510(k) premarket notification submitted by Changzhou Holymed Products Co., Ltd. for the device "HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGICAL GOWN, POLYERINFORCED". The FDA issued a decision of Substantially Equivalent on December 20, 2012. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Changzhou Holymed Products Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2012
- Date Received
- July 9, 2012
- 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