510(k) K923577
K923577 is an FDA 510(k) premarket notification submitted by Medela, Inc. for the device "BREAST SHELLS". The FDA issued a decision of Substantially Equivalent on Jan 22, 1993. The device falls under product code HFS (Shield, Nipple), a Class I device regulated under 21 CFR 880.5630. Medela, Inc. has 55 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 22, 1993
- Date Received
- Jul 20, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Shield, Nipple
- Device Class
- Class I
- Regulation Number
- 880.5630
- Review Panel
- HO
- Submission Type
- 510(k) Exempt