The following data is part of a premarket notification filed by Quality System Consulting with the FDA for Phaseal, System For Sealed Handling Of Chemotherapeutic Agents.
| Device ID | K972527 |
| 510k Number | K972527 |
| Device Name: | PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS |
| Classification | Set, Administration, Intravascular |
| Applicant | QUALITY SYSTEM CONSULTING 1425 CRESSA COURT Carlsbad, CA 92009 |
| Contact | Fred Schlador |
| Correspondent | Fred Schlador QUALITY SYSTEM CONSULTING 1425 CRESSA COURT Carlsbad, CA 92009 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-07 |
| Decision Date | 1997-09-18 |
| Summary: | summary |