The following data is part of a premarket notification filed by Hangzhou Jincheng Medical Supplier Manufacture Co. with the FDA for Sms Gowns (reinforced And Reinforced With Guider), Spunlace Gowns (regular, Regular With Guider), Spunlace Gowns (reinfo.
| Device ID | K102692 |
| 510k Number | K102692 |
| Device Name: | SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO |
| Classification | Gown, Surgical |
| Applicant | HANGZHOU JINCHENG MEDICAL SUPPLIER MANUFACTURE CO. 5 CAREY STREET Pennington, NJ 08534 |
| Contact | Chengyu Shen |
| Correspondent | Chengyu Shen HANGZHOU JINCHENG MEDICAL SUPPLIER MANUFACTURE CO. 5 CAREY STREET Pennington, NJ 08534 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-20 |
| Decision Date | 2011-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14710415369410 | K102692 | 000 |
| 14710415369243 | K102692 | 000 |
| 14710415369236 | K102692 | 000 |
| 14710415369229 | K102692 | 000 |
| 04710415369215 | K102692 | 000 |
| 04710415369208 | K102692 | 000 |
| 14710415369199 | K102692 | 000 |
| 14710415369182 | K102692 | 000 |
| 14710415369175 | K102692 | 000 |
| 14710415369168 | K102692 | 000 |
| 14710415369151 | K102692 | 000 |
| 14710415369144 | K102692 | 000 |
| 14710415369137 | K102692 | 000 |
| 14710415369120 | K102692 | 000 |
| 14710415369113 | K102692 | 000 |
| 14710415369250 | K102692 | 000 |
| 14710415369267 | K102692 | 000 |
| 04710415369406 | K102692 | 000 |
| 14710415369397 | K102692 | 000 |
| 14710415369380 | K102692 | 000 |
| 14710415369373 | K102692 | 000 |
| 14710415369366 | K102692 | 000 |
| 14710415369359 | K102692 | 000 |
| 14710415369342 | K102692 | 000 |
| 14710415369335 | K102692 | 000 |
| 14710415369328 | K102692 | 000 |
| 14710415369311 | K102692 | 000 |
| 14710415369304 | K102692 | 000 |
| 14710415369298 | K102692 | 000 |
| 14710415369281 | K102692 | 000 |
| 04710415369277 | K102692 | 000 |
| 14710415369106 | K102692 | 000 |