The following data is part of a premarket notification filed by Barnstead/thermolyne Corp. with the FDA for Harvey Pv Dry Sterilizer, Model # St127325; St127320; St127320-33.
| Device ID | K014174 |
| 510k Number | K014174 |
| Device Name: | HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-33 |
| Classification | Sterilizer, Steam |
| Applicant | BARNSTEAD/THERMOLYNE CORP. P.O. BOX 797 Dubuque, IA 52001 |
| Contact | Mia M Ware |
| Correspondent | Reiner Krumme TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-12-20 |
| Decision Date | 2002-02-22 |
| Summary: | summary |