The following data is part of a premarket notification filed by Swemed Lab International Ab with the FDA for Swemed Intracytoplasmic Sperm Injection (icsi) Micro-injection Pipettes; Holding Pipttes; Denuding Pipettes; Assisted/zo.
| Device ID | K991700 |
| 510k Number | K991700 |
| Device Name: | SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO |
| Classification | Microtools, Assisted Reproduction (pipettes) |
| Applicant | SWEMED LAB INTERNATIONAL AB BILLDALSVAGEN 2 Billdal, SE Se-427 36 |
| Contact | Edward C Wilson |
| Correspondent | Edward C Wilson SWEMED LAB INTERNATIONAL AB BILLDALSVAGEN 2 Billdal, SE Se-427 36 |
| Product Code | MQH |
| CFR Regulation Number | 884.6130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-18 |
| Decision Date | 1999-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17350025914135 | K991700 | 000 |
| 17350025911875 | K991700 | 000 |
| 17350025911868 | K991700 | 000 |
| 17350025911844 | K991700 | 000 |
| 17350025911820 | K991700 | 000 |
| 17350025911813 | K991700 | 000 |
| 17350025911806 | K991700 | 000 |
| 17350025911783 | K991700 | 000 |
| 17350025911769 | K991700 | 000 |
| 17350025911745 | K991700 | 000 |
| 17350025911738 | K991700 | 000 |
| 17350025911721 | K991700 | 000 |
| 17350025911707 | K991700 | 000 |
| 17350025911899 | K991700 | 000 |
| 17350025911912 | K991700 | 000 |
| 17350025914081 | K991700 | 000 |
| 17350025912179 | K991700 | 000 |
| 17350025912155 | K991700 | 000 |
| 17350025912124 | K991700 | 000 |
| 17350025912100 | K991700 | 000 |
| 17350025912087 | K991700 | 000 |
| 17350025912063 | K991700 | 000 |
| 17350025912018 | K991700 | 000 |
| 17350025911967 | K991700 | 000 |
| 17350025911950 | K991700 | 000 |
| 17350025911943 | K991700 | 000 |
| 17350025911929 | K991700 | 000 |
| 17350025911691 | K991700 | 000 |