510(k) K760360
K760360 is an FDA 510(k) premarket notification submitted by Precept, Inc. for the device "SHIRT, MITTEN CUFF INFANT". The FDA issued a decision of Substantially Equivalent on October 20, 1976. The device falls under product code FME (Gown, Examination), a Class I device regulated under 21 CFR 880.6265. Precept, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 1976
- Date Received
- August 2, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gown, Examination
- Device Class
- Class I
- Regulation Number
- 880.6265
- Review Panel
- HO
- Submission Type