The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for Quantum 3080 Surgical Table.
Device ID | K930493 |
510k Number | K930493 |
Device Name: | QUANTUM 3080 SURGICAL TABLE |
Classification | Table, Operating-room, Ac-powered |
Applicant | AMERICAN STERILIZER CO. 2424 WEST 23RD ST. P.O. BOX 620 Erie, PA 16514 |
Contact | Michael Zmuda |
Correspondent | Michael Zmuda AMERICAN STERILIZER CO. 2424 WEST 23RD ST. P.O. BOX 620 Erie, PA 16514 |
Product Code | FQO |
CFR Regulation Number | 878.4960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-01 |
Decision Date | 1993-06-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00724995155018 | K930493 | 000 |