510(k) K844938
K844938 is an FDA 510(k) premarket notification submitted by Pfizer, Inc. for the device "UNITED SKIN BARRIERS". The FDA issued a decision of Substantially Equivalent on January 18, 1985. The device falls under product code EXB (Collector, Ostomy), a Class I device regulated under 21 CFR 876.5900. Pfizer, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 1985
- Date Received
- December 20, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Collector, Ostomy
- Device Class
- Class I
- Regulation Number
- 876.5900
- Review Panel
- GU
- Submission Type