SAFE-T-SEAL

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

GS MEDICAL PACKAGING, INC.

The following data is part of a premarket notification filed by Gs Medical Packaging, Inc. with the FDA for Safe-t-seal.

Pre-market Notification Details

• Device ID: K953829
• 510k Number: K953829
• Device Name: SAFE-T-SEAL
• Classification: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
• Applicant: GS MEDICAL PACKAGING, INC. 6890 PACIFIC CIRCLE Mississauga, Ontario, CA L5t 1n8
• Contact: John Sherlock
• Correspondent: John Sherlock; GS MEDICAL PACKAGING, INC. 6890 PACIFIC CIRCLE Mississauga, Ontario, CA L5t 1n8
• Product Code: KCT
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-08-16
• Decision Date: 1995-11-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D8302222181	K953829	000
D8302216331	K953829	000
D8302216321	K953829	000
D8302216311	K953829	000
D8302216281	K953829	000
D830221442RXEU0	K953829	000
D8302214420	K953829	000
D830221439RX0	K953829	000
D8302214390	K953829	000
D830221438RXEU0	K953829	000
D8302214360	K953829	000
D830221434RXEU0	K953829	000
D830221434RX0	K953829	000
D830221633UNPT1	K953829	000
D8302216341	K953829	000
D8302216361	K953829	000
D8302221041	K953829	000
D830222103B2	K953829	000
D8302221031	K953829	000
D8302221021	K953829	000
D8302221011	K953829	000
D8302221001	K953829	000
D8302216461	K953829	000
D8302216451	K953829	000
D8302216411	K953829	000
D8302216401	K953829	000
D8302216391	K953829	000
D8302216381	K953829	000
D8302214341	K953829	000
D8302214330	K953829	000
D830221432	K953829	000
D6870083000FG2	K953829	000
D830500000112	K953829	000
D830500000102	K953829	000
D830500000091	K953829	000
D83050000081	K953829	000
H816MPM75132	K953829	000
H816MPM54102	K953829	000
H816MPM35902	K953829	000
H816MPM35542	K953829	000
H816MPM27902	K953829	000
H816MPM24402	K953829	000
H816MPM13180	K953829	000
D6870083001FG2	K953829	000
D6870083003FG2	K953829	000
D6870083005FG2	K953829	000
D6870088020FG2	K953829	000
D6870088015FG2	K953829	000
D6870088010FG2	K953829	000
D6870088005FG2	K953829	000
D6870088000FG2	K953829	000
D6870083080FG2	K953829	000
D6870083075FG2	K953829	000
D6870083045FG2	K953829	000
D6870083025FG2	K953829	000
D6870083020FG2	K953829	000
D6870083015FG2	K953829	000
D6870083010FG2	K953829	000
H816MPM10160	K953829	000
D830221632BL1	K953829	000
D830SW20201	K953829	000
D830SW15151	K953829	000
D830OM3090UNPRT2	K953829	000
D830OM30902	K953829	000
D830OM0410P9382	K953829	000
D830OM0410P9202	K953829	000
D8305716202	K953829	000
D8305711142	K953829	000
D8305612182	K953829	000
D8305612152	K953829	000
D8305608132	K953829	000
D8305605102	K953829	000
D830SW24241	K953829	000
D830SW30301	K953829	000
D830SW36361	K953829	000
H816PM75132	K953829	000
H816PM54102	K953829	000
H816PM35902	K953829	000
H816PM35542	K953829	000
H816PM27902	K953829	000
H816PM24402	K953829	000
H816PM13191	K953829	000
H816PM13181	K953829	000
H816PM10161	K953829	000
D830VWR891408042	K953829	000
D830VWR891408022	K953829	000
D830VWR891408002	K953829	000
D8305518311	K953829	000
D830551442PC0	K953829	000
D8305514420	K953829	000
D8305503072	K953829	000
D8305503052	K953829	000
D8304421031	K953829	000
D8304421021	K953829	000
D830442101BULK2	K953829	000
D8304421011	K953829	000
D8304421001	K953829	000
D8304420901	K953829	000
D8304420892	K953829	000
D8304410161	K953829	000
D8302228162	K953829	000
D8302225651	K953829	000
D8305504092	K953829	000
D8305506072	K953829	000
D8305506102	K953829	000
D8305514400	K953829	000
D8305514380	K953829	000
D830551436PC0	K953829	000
D8305514360	K953829	000
D8305514340	K953829	000
D8305514330	K953829	000
D8305514320	K953829	000
D8305512182	K953829	000
D8305512152	K953829	000
D830551015T2	K953829	000
D8305510152	K953829	000
D8305508122	K953829	000
D8302225552	K953829	000