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 |