510(k) K030536
K030536 is an FDA 510(k) premarket notification submitted by Lac Mac, Ltd. for the device "LAC-MAC LIMITED INNERBLOC O.R. GOWN". The FDA issued a decision of Substantially Equivalent on May 6, 2003. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Lac Mac, Ltd. has 5 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 2003
- Date Received
- Feb 20, 2003
- 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)