The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for General Surgical Table And Accessories.
Device ID | K882660 |
510k Number | K882660 |
Device Name: | GENERAL SURGICAL TABLE AND ACCESSORIES |
Classification | Table, Operating-room, Ac-powered |
Applicant | AMERICAN STERILIZER CO. 2222 WEST GRANDVIEW BLVD. Erie, PA 16512 |
Contact | Ronald B Bartone |
Correspondent | Ronald B Bartone AMERICAN STERILIZER CO. 2222 WEST GRANDVIEW BLVD. Erie, PA 16512 |
Product Code | FQO |
CFR Regulation Number | 878.4960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-28 |
Decision Date | 1988-07-25 |