510(k) K771929
K771929 is an FDA 510(k) premarket notification submitted by Convertors for the device "PEDIATRICS GOWN". The FDA issued a decision of Substantially Equivalent on November 16, 1977. The device falls under product code FYB (Gown, Patient), a Class II device regulated under 21 CFR 878.4040. Convertors has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 1977
- Date Received
- October 14, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gown, Patient
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type