The following data is part of a premarket notification filed by Swemed Laboratories, Inc. with the FDA for Needle For Amniocentesis And Cyst Puncture.
| Device ID | K862365 |
| 510k Number | K862365 |
| Device Name: | NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE |
| Classification | Sampler, Amniotic Fluid (amniocentesis Tray) |
| Applicant | SWEMED LABORATORIES, INC. FULLRIGGAREGATAN 12 B S-421 74 V.FROLUNDA Sweden, SE |
| Contact | Goran Itskowitz |
| Correspondent | Goran Itskowitz SWEMED LABORATORIES, INC. FULLRIGGAREGATAN 12 B S-421 74 V.FROLUNDA Sweden, SE |
| Product Code | HIO |
| CFR Regulation Number | 884.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-24 |
| Decision Date | 1986-07-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17350025912414 | K862365 | 000 |
| 07350025912301 | K862365 | 000 |
| 17350025912315 | K862365 | 000 |
| 07350025912325 | K862365 | 000 |
| 07350025912332 | K862365 | 000 |
| 17350025912346 | K862365 | 000 |
| 17350025912360 | K862365 | 000 |
| 07350025912370 | K862365 | 000 |
| 17350025912384 | K862365 | 000 |
| 17350025912391 | K862365 | 000 |
| 17350025912285 | K862365 | 000 |