The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Potocky Neddle (tm) Disposable Injection Needle.
| Device ID | K910252 |
| 510k Number | K910252 |
| Device Name: | POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE |
| Classification | Set, Anesthesia, Paracervical |
| Applicant | COOPERSURGICAL, INC. C/O CHARLES I. ROSE & CO., INC 1963 ROCK STREET, SUITE #17 Mountain View, CA 94043 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose COOPERSURGICAL, INC. C/O CHARLES I. ROSE & CO., INC 1963 ROCK STREET, SUITE #17 Mountain View, CA 94043 |
| Product Code | HEE |
| CFR Regulation Number | 884.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-22 |
| Decision Date | 1991-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937010934 | K910252 | 000 |
| 20888937010927 | K910252 | 000 |