510(k) K875166
K875166 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "PHARMASEAL STERILE UMBILICAL CORD CLAMP". The FDA issued a decision of Substantially Equivalent on Mar 2, 1988. The device falls under product code HWI (Corkscrew), a Class I device regulated under 21 CFR 888.4540. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 2, 1988
- Date Received
- Dec 17, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Corkscrew
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type
- 510(k) Exempt