The following data is part of a premarket notification filed by Marlow Surgical Technologies, Inc. with the FDA for Wallace Artificial Insemination Catheter - 8cm/18cm.
| Device ID | K964848 |
| 510k Number | K964848 |
| Device Name: | WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM |
| Classification | Cannula, Intrauterine Insemination |
| Applicant | MARLOW SURGICAL TECHNOLOGIES, INC. 1810 JOSEPH LLOYD PKWY. Willoughby, OH 44094 |
| Contact | Arthur S Goddard |
| Correspondent | Arthur S Goddard MARLOW SURGICAL TECHNOLOGIES, INC. 1810 JOSEPH LLOYD PKWY. Willoughby, OH 44094 |
| Product Code | MFD |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-03 |
| Decision Date | 1997-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30888937021333 | K964848 | 000 |