The following data is part of a premarket notification filed by Panpac Medical Corporation with the FDA for The Panpac Suction Curette.
| Device ID | K092982 |
| 510k Number | K092982 |
| Device Name: | THE PANPAC SUCTION CURETTE |
| Classification | Curette, Suction, Endometrial (and Accessories) |
| Applicant | Panpac Medical Corporation NO. 202, 6F-1.2, SEC.3 TATONG ROAD Shi-chih City, Taipei Hsien, TW 22103 |
| Contact | Yen-ming Pan |
| Correspondent | Yen-ming Pan Panpac Medical Corporation NO. 202, 6F-1.2, SEC.3 TATONG ROAD Shi-chih City, Taipei Hsien, TW 22103 |
| Product Code | HHK |
| CFR Regulation Number | 884.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-28 |
| Decision Date | 2010-07-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04715309129395 | K092982 | 000 |
| 04719894432311 | K092982 | 000 |
| 04719894432328 | K092982 | 000 |
| 04719894432403 | K092982 | 000 |
| 04719894433370 | K092982 | 000 |
| 20888277632148 | K092982 | 000 |
| 20888277632155 | K092982 | 000 |
| 20888277632162 | K092982 | 000 |
| H8343030101 | K092982 | 000 |
| H8343030121 | K092982 | 000 |
| H8343030151 | K092982 | 000 |
| 04715309122044 | K092982 | 000 |
| 04715309121993 | K092982 | 000 |
| 04715309122068 | K092982 | 000 |
| 04715309122051 | K092982 | 000 |
| 04715309122938 | K092982 | 000 |
| 04719894432335 | K092982 | 000 |