The following data is part of a premarket notification filed by Zhejiang Gongdong Medical Plastic Factory with the FDA for Gongdong Disposable Vaginal Speculum.
| Device ID | K050887 |
| 510k Number | K050887 |
| Device Name: | GONGDONG DISPOSABLE VAGINAL SPECULUM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | ZHEJIANG GONGDONG MEDICAL PLASTIC FACTORY BEICHENG INDUSTRIAL AREA Huangyan, CN 318020 |
| Contact | Weifeng Zhong |
| Correspondent | Weifeng Zhong ZHEJIANG GONGDONG MEDICAL PLASTIC FACTORY BEICHENG INDUSTRIAL AREA Huangyan, CN 318020 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-07 |
| Decision Date | 2005-07-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10304040016807 | K050887 | 000 |
| 20612479188536 | K050887 | 000 |
| 20612479188550 | K050887 | 000 |
| 20612479188574 | K050887 | 000 |
| 20612479189090 | K050887 | 000 |
| 20612479189113 | K050887 | 000 |
| 20612479189137 | K050887 | 000 |
| 00811382011115 | K050887 | 000 |
| 00811382011122 | K050887 | 000 |
| 00811382011139 | K050887 | 000 |
| 10304040001285 | K050887 | 000 |
| 10304040001292 | K050887 | 000 |
| 10304040001308 | K050887 | 000 |
| 10304040016784 | K050887 | 000 |
| 10304040016791 | K050887 | 000 |
| 30080196806472 | K050887 | 000 |