The following data is part of a premarket notification filed by Medipack Medical Packaging Mfg. Co. with the FDA for Medipack See-through Seal Sterilization Pouch.
Device ID | K993764 |
510k Number | K993764 |
Device Name: | MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | MEDIPACK MEDICAL PACKAGING MFG. CO. 9109 COPENHAVER DR. Potomac, MD 20854 |
Contact | Norman F Estrin |
Correspondent | Norman F Estrin MEDIPACK MEDICAL PACKAGING MFG. CO. 9109 COPENHAVER DR. Potomac, MD 20854 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-11-08 |
Decision Date | 1999-12-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D784UPP75131 | K993764 | 000 |
D784UPP2231 | K993764 | 000 |
D784UPP12181 | K993764 | 000 |
D784UPP10151 | K993764 | 000 |
D784UPT0065 | K993764 | 000 |
D784UPT0045 | K993764 | 000 |
D784UPT0035 | K993764 | 000 |
D784UPT0025 | K993764 | 000 |
D784UPST1005 | K993764 | 000 |
D784UPST0755 | K993764 | 000 |
D784UPP2251 | K993764 | 000 |
D784UPP27101 | K993764 | 000 |
D784UPP52751 | K993764 | 000 |
D784UPP52111 | K993764 | 000 |
D784UPP42121 | K993764 | 000 |
D784UPP35651 | K993764 | 000 |
D784UPP35101K1 | K993764 | 000 |
D784UPP35101 | K993764 | 000 |
D784UPP32121 | K993764 | 000 |
D784UPP291 | K993764 | 000 |
D784UPP27101K1 | K993764 | 000 |
D784UPST0505 | K993764 | 000 |