SURGAIRTOME TWO
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment
AMERICAN STERILIZER CO.
The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for Surgairtome Two.
Pre-market Notification Details
| Device ID | K781979 |
| 510k Number | K781979 |
| Device Name: | SURGAIRTOME TWO |
| Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Applicant | AMERICAN STERILIZER CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HSZ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-27 |
| Decision Date | 1978-12-20 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30845854018921 | K781979 | 000 |
Trademark Results [SURGAIRTOME TWO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURGAIRTOME TWO 73371064 1278827 Live/Registered |
American Sterilizer Company 1982-06-23 |
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