The following data is part of a premarket notification filed by Intl. Medical, Inc. with the FDA for Amcath Suction-irrigation Tube.
| Device ID | K900988 |
| 510k Number | K900988 |
| Device Name: | AMCATH SUCTION-IRRIGATION TUBE |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | INTL. MEDICAL, INC. 175 CONNECTICUT MILLS AVE. Danielson, CT 06239 |
| Contact | H Wettermann |
| Correspondent | H Wettermann INTL. MEDICAL, INC. 175 CONNECTICUT MILLS AVE. Danielson, CT 06239 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-02 |
| Decision Date | 1990-05-07 |