510(k) K933619
K933619 is an FDA 510(k) premarket notification submitted by General Medical Mfg. Co. for the device "PD-PAK". The FDA issued a decision of Substantially Equivalent on February 22, 1994. The device falls under product code MLW (Warmer, Peritoneal Dialysate), a Class II device regulated under 21 CFR 876.5630.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 1994
- Date Received
- July 19, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Warmer, Peritoneal Dialysate
- Device Class
- Class II
- Regulation Number
- 876.5630
- Review Panel
- GU
- Submission Type