The following data is part of a premarket notification filed by Porter Instrument Co., Inc. with the FDA for Steam Sterilizer (autoclave), Dental.
| Device ID | K895638 |
| 510k Number | K895638 |
| Device Name: | STEAM STERILIZER (AUTOCLAVE), DENTAL |
| Classification | Sterilizer, Steam |
| Applicant | PORTER INSTRUMENT CO., INC. 245 TOWNSHIP LINE RD. P.O. BOX 907 Hatfield, PA 19440 -0907 |
| Contact | Luich, P.e. |
| Correspondent | Luich, P.e. 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 | 1989-09-19 |
| Decision Date | 1990-02-22 |