The following data is part of a premarket notification filed by Scican with the FDA for Stat Im 5000 Cassette Autoclave.
Device ID | K962179 |
510k Number | K962179 |
Device Name: | STAT IM 5000 CASSETTE AUTOCLAVE |
Classification | Sterilizer, Steam |
Applicant | SCICAN 2002 SMALLMAN ST. Pittsburgh, PA 15222 |
Contact | Neil Mcphail |
Correspondent | Neil Mcphail SCICAN 2002 SMALLMAN ST. Pittsburgh, PA 15222 |
Product Code | FLE |
CFR Regulation Number | 880.6880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-06 |
Decision Date | 1997-01-13 |
Summary: | summary |