510(k) K160595
- Device
- PMSSteripack Tyvek Sterilization Pouch (TP) And Roll (TY) With Chemical Indicator
- Applicant
- PMS Medikal Ambalaj Sanayi Ve Ticaret LTD STI
- 510(k) number
- K160595
- Product code
- FRG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-11-18
- Date received
- 2016-03-01
- 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
- No
Applicant Contact#
- Contact
- Derya Dikici
- Address
- Karaduvar Mah.Serbest Bolge, 11.Cad #46 Mersin Serbest Bolgesi, Akdeniz Mersin TR 33020 33020
FDA Registration Numbers#
- 9680845
- 1054380
- 3015231789
- 3004122598
- 3038191347
- 9615270
- 3005061536
- 3017220525
- 3008770655
- 2435946
- 2024980
- 3019848304
- 1056276
- 1032227
- 3015633688
- 3005748481
- 3013298431
- 9613277
- 3003418325
- 1834190
- 1017294
- 2031508
- 2431166
- 9616088
- 1643264
- 3014456066
- 3017949824
- 2023811
- 3009968482
- 1319130
- 3011279497
- 1221053
- 2183301
- 2648727
- 3010147274
- 3013187142
- 2242656
- 3015895045
- 3045855232
- 3006847937
- 2029015
- 3008132392
- 3044322716
- 8030674
- 3012345110
- 3043051314
- 1043214
- 2183785
- 3011533888
- 3024787345
- 1723170
- 3004143450
- 3021361802
- 9616096
- 1423537
- 1217231
- 3005599545
- 3029802606
- 3009443860
- 3009219448
- 3021010394
- 2916714
- 2011171
- 3001644167
- 3036679484
- 2024312
- 3016761372
- 1054241
- 3015820879
- 3004488394
- 1320894
- 3018047916
- 3044819802
- 3007034244
- 3024088964
- 3038138452
- 2410251
- 8022129
- 3016928862
- 3004133257
Source Documents#
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#
summary
FDA Review#
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