The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Endocervical Block Needle.
| Device ID | K021224 |
| 510k Number | K021224 |
| Device Name: | ENDOCERVICAL BLOCK NEEDLE |
| Classification | Set, Anesthesia, Paracervical |
| Applicant | WALLACH SURGICAL DEVICES, INC. 235 EDISON RD. Orange, CT 06477 |
| Contact | Michael Malis |
| Correspondent | Michael Malis WALLACH SURGICAL DEVICES, INC. 235 EDISON RD. Orange, CT 06477 |
| Product Code | HEE |
| CFR Regulation Number | 884.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-17 |
| Decision Date | 2002-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937011214 | K021224 | 000 |
| 20888937011207 | K021224 | 000 |