510(k) K823513
- Device
- CENTRAL SUPPLY ROOM WRAP
- Applicant
- JAMES RIVER CORP.
- 510(k) number
- K823513
- Product code
- FRG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-01-07
- Date received
- 1982-11-29
- Regulation
- 880.6850
- Classification name
- Wrap, Sterilization
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 1834190
- 3007034244
- 3013557562
- 3009307523
- 3016678045
- 3009443860
- 3016928862
- 3012421755
- 1055892
- 9610612
- 3003418325
- 3004488394
- 9615270
- 1217231
- 3008572101
- 1724474
- 1053306
- 2242656
- 1417592
- 3021013267
- 1055236
- 9680031
- 1527607
- 3018781093
- 1423537
- 1056276
- 3005599545
- 1043644
- 8030674
- 3004193466
- 3010598169
- 1032347
- 3004753358
- 1526531
- 9611959
- 9680357
- 2183301
- 2511556
- 3016851379
- 3044322716
- 3003495693
- 3035642068
- 3009750712
- 3006723155
- 1418005
- 2437780
- 3044819802
- 8022129
- 1723170
- 3002579136
- 3014683120
- 2183785
- 1828464
- 1527185
- 3010864832
- 3004362278
- 3009219448
- 1032227
- 3017230778
- 3005180920
- 3042191618
- 3036622014
- 3005061536
- 2182318
- 3008559238
- 3038718579
- 3016075971
- 2523320
- 3013596742
- 3001644167
- 1836161
- 3007289408
- 1319130
- 3042285072
- 3021361802
- 3036679484
- 9616872
- 3011497662
- 3007339875
- 3004080920
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FRG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261897 | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology | O&M Halyard, Inc. | 2026-07-02 |
| K252823 | Dukal Crepe Paper Sterilization Wrap | Dukal, LLC | 2026-05-28 |
| K253454 | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap | O&M Halyard, Inc. | 2026-05-18 |
| 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 |
| K241565 | Sterilization Package/Reel | Anqing Clean Dental Instrument Technology Co., Ltd. | 2025-02-24 |
| K242898 | Sterilization Pouches and Reels | Shanghai Jianzhong Medical Packaging Co., Ltd. | 2025-02-21 |
| K243431 | Medicom Sterilization Pouch and Reel | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. | 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases