The following data is part of a premarket notification filed by Acuderm, Inc. with the FDA for Acu-curette.
| Device ID | K891334 |
| 510k Number | K891334 |
| Device Name: | ACU-CURETTE |
| Classification | Curette, Surgical, General Use |
| Applicant | ACUDERM, INC. 5370 N.W. 35TH TERRACE Ft. Lauderdale, FL 33309 |
| Contact | Charles R Yeh |
| Correspondent | Charles R Yeh ACUDERM, INC. 5370 N.W. 35TH TERRACE Ft. Lauderdale, FL 33309 |
| Product Code | FZS |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-10 |
| Decision Date | 1989-04-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814105021323 | K891334 | 000 |
| 00814105021316 | K891334 | 000 |
| 00814105020050 | K891334 | 000 |
| 00814105020043 | K891334 | 000 |
| 00814105020036 | K891334 | 000 |
| 00814105020029 | K891334 | 000 |
| 00814105020012 | K891334 | 000 |
| 00814105020005 | K891334 | 000 |