The following data is part of a premarket notification filed by Texas Medical Products, Inc. with the FDA for Air Aspirator Needle.
| Device ID | K801393 |
| 510k Number | K801393 |
| Device Name: | AIR ASPIRATOR NEEDLE |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | TEXAS MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-13 |
| Decision Date | 1980-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B0662010150000 | K801393 | 000 |
| B0662010100006 | K801393 | 000 |
| B0662010050006 | K801393 | 000 |
| B066201015NS1 | K801393 | 000 |
| B066201010NS1 | K801393 | 000 |
| B066201005NS6 | K801393 | 000 |