The following data is part of a premarket notification filed by Porter Instrument Co., Inc. with the FDA for Ses-2012 Automatic Steam Sterilizer.
Device ID | K924596 |
510k Number | K924596 |
Device Name: | SES-2012 AUTOMATIC STEAM STERILIZER |
Classification | Sterilizer, Steam |
Applicant | PORTER INSTRUMENT CO., INC. 245 TOWNSHIP LINE RD. P.O. BOX 907 Hatfield, PA 19440 -0907 |
Contact | Stephen D Loeffler |
Correspondent | Stephen D Loeffler PORTER INSTRUMENT CO., INC. 245 TOWNSHIP LINE RD. P.O. BOX 907 Hatfield, PA 19440 -0907 |
Product Code | FLE |
CFR Regulation Number | 880.6880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-11 |
Decision Date | 1994-04-15 |