510(k) K241565
- Device
- Sterilization Package/Reel
- Applicant
- Anqing Clean Dental Instrument Technology Co., Ltd.
- 510(k) number
- K241565
- Product code
- FRG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-02-24
- Date received
- 2024-05-31
- Regulation
- 880.6850
- Classification name
- Wrap, Sterilization
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Wu Yiming
- Address
- Floor 2, D4-A, Jiabao Industrial Park.Yangtze River Bridge Economic Development Zone Anqing CN 246000 246000
FDA Registration Numbers
- 3044322716
- 3004488394
- 1834190
- 3005180920
- 3015895045
- 3004362278
- 1043644
- 1032227
- 3038138452
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- 1320894
- 3011497662
- 3010598169
Source Documents
Other 510(k) Records For Product Code FRG
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251347 | Sterilization Pouch/Roll | Sterivic Medical Co., Ltd. | 2026-01-28 |
| K251177 | Self-Seal Sterilization Pouch and Roll | Guangdong Maidi Medical Co., Ltd. | 2025-12-12 |
| K250306 | Chex-All Sterilization Pouches and Tubes | Propper Manufacturing Co., Inc. | 2025-10-31 |
| K243179 | Sterilization Pouch and Roll | Yichang Xinxin Paper Products Co., Ltd. | 2025-06-26 |
| K250321 | GCI Sterilization Wrappers | George Courey, Inc. | 2025-06-06 |
| K243721 | Self Sealing Sterilization Pouches | Wellmed Dental Medical Supply Co., Ltd. | 2025-04-25 |
| K250011 | Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) | Turbett Surgical | 2025-04-04 |
| K243431 | Medicom Sterilization Pouch and Reel | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. | 2025-02-21 |
| K242898 | Sterilization Pouches and Reels | Shanghai Jianzhong Medical Packaging Co., Ltd. | 2025-02-21 |
| K240438 | CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm) | Comercializadora Brever | 2024-11-04 |
| K242839 | Safe Secure Sterilization Pouches and Rolls | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | 2024-10-16 |
| K242208 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | Primed Medical Products, Inc. | 2024-10-07 |
| K241123 | Perpak Sterilization Tyvek Pouch | Km Corp. | 2024-09-18 |
| K234132 | Medline Reusable Sterilization Wrappers | Medline Industries, LP | 2024-09-17 |
| K234050 | HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap | O&M Halyard, Inc. | 2024-09-16 |