The following data is part of a premarket notification filed by Cymed, Inc. with the FDA for Cymed Microskin(r) Disposable Irrigation Sleeve.
| Device ID | K892521 |
| 510k Number | K892521 |
| Device Name: | CYMED MICROSKIN(R) DISPOSABLE IRRIGATION SLEEVE |
| Classification | Curette, Surgical, General Use |
| Applicant | CYMED, INC. 3447 INVESTMENT BLVD. Hayward, CA 94545 |
| Contact | Donald A Deroeck |
| Correspondent | Donald A Deroeck CYMED, INC. 3447 INVESTMENT BLVD. Hayward, CA 94545 |
| Product Code | FZS |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-11 |
| Decision Date | 1989-05-01 |