510(k) K885185
K885185 is an FDA 510(k) premarket notification submitted by Intera Corp. for the device "INTERA SHIELD AND INTERA UNDERGARMENT". The FDA issued a decision of Substantially Equivalent on February 8, 1989. The device falls under product code EYQ (Garment, Protective, For Incontinence), a Class I device regulated under 21 CFR 876.5920. Intera Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 1989
- Date Received
- December 14, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Garment, Protective, For Incontinence
- Device Class
- Class I
- Regulation Number
- 876.5920
- Review Panel
- GU
- Submission Type